Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps

Q: Who is the manufacturer of Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps?

Modern Medical Equipment Manufacturing, Ltd. filed the 510(k) submission for Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps (K210315).

Q: What is the FDA product code for Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K210315 · Modern Medical Equipment Manufacturing, Ltd. · GEI · Mar 17, 2022 · General, Plastic Surgery

Device Facts

Record ID	K210315
Device Name	Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps
Applicant	Modern Medical Equipment Manufacturing, Ltd.
Product Code	GEI · General, Plastic Surgery
Decision Date	Mar 17, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The device is intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical coagulation is desired during surgery and are intended to grasp, manipulate coagulate selected soft tissue.

Device Story

Active electrosurgical instruments (monopolar or bipolar forceps) designed to grasp, manipulate, and coagulate soft tissue. Devices connect to an electrosurgical generator via cable; deliver electrosurgical current to target tissue. Models CD954 and CD955 include integrated smoke evacuation functionality to remove surgical smoke generated during procedures. Used in hospital settings by clinicians. Forceps are single-use, sterile (EtO), and constructed from stainless steel. Output affects clinical decision-making by enabling precise tissue coagulation and improved visualization via smoke removal, potentially reducing surgical smoke exposure for the surgical team.

Clinical Evidence

Bench testing only. Performance testing included comparative use on porcine tissue (kidney, liver, muscle) in both cut and coagulation modes per FDA guidance. Biocompatibility testing (cytotoxicity, sensitization, systemic toxicity) performed per ISO 10993. Electrical safety verified per IEC 60601-1 and IEC 60601-2-2.

Technological Characteristics

Stainless steel forceps; single-use; EtO sterilized. Rated accessory voltage 2.0kVp. Connectivity via standard electrosurgical cables to generators. Tip sizes 0.1-1.2mm. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.

Indications for Use

Indicated for patients requiring electrosurgical coagulation of soft tissue during surgical procedures. No specific age or gender restrictions.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Olsen Medical SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS (K130669)
Modern Medical Smoke Evacuation Fingerswitch, Smoke Evacuation System With Electrosurgical Pencil (K200372)
Modern Medical Bipolar Forceps (K032327)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 17, 2022 Modern Medical Equipment Manufacturing, LTD. Mr. Philip Hung QA Manager / Management Representative Unit A, 10/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street. Kwai Chung, N.T., Hong Kong, China Re: K210315 Trade/Device Name: Monopolar and Bipolar Forceps (with and without Smoke Evacuation). Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 04, 2022 Received: January 26, 2022 # Dear Mr. Hung: We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of {1}------------------------------------------------ Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K210315 #### Device Name Monopolar and Bipolar Forceps ( with and without Smoke Evacuation) Indications for Use (Describe) 1. Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. 2. Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. 3. Single Use Hand Switch Monopolar Forceps (CD956) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure. 4. Single Use Hand Switch Bipolar Forceps (CD957) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | 1. 510(k) Owner Name: | | Modern Medical Equipment Manufacturing Limited | |--------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------| | Address: | | Modern Medical Equipment Mfg., Ltd. Unit A, 10/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street, Kwai Chung, N.T., Hong Kong, China. | | Telephone: | | (852) 2420 9068 | | Fax: | | (852) 2481 1234 | | Contact person: | | Mr. Philip Hung | | Position: | | Quality Assurance Manager / Management Representative | | Email Address: | | philip_hung@modernmedical.com.hk | | Date of preparation: | | Feb14, 2022 | | 2. Device | | | | Device Trade name: | | Monopolar and Bipolar Forceps ( with and without Smoke Evacuation) | | Common or usual name: | | Single Use Hand Switch Monopolar and Bipolar Forceps Single Use Hand Switch Monopolar and Bipolar Forceps with Smoke Evacuation. | | Classification name: | | Electrosurgical Cutting & Coagulation Device & Accessories | | Classification number: | | 21 CFR 878.4400 | | Classification Panel: | | General & Plastic Surgery | | Product Code: | | GEI | | Class: | | II | ### 3. Predicate device 3.1 Olsen Medical SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS with 510(k) number K130669, cleared Dec 06,2013. {4}------------------------------------------------ 3.2 Modern Medical Smoke Evacuation Fingerswitch, Smoke Evacuation System With Electrosurgical Pencil with 510(k) number K200372, cleared Nov 30, 2020. 3.3 Modern Medical Bipolar Forceps with 510(k) number K032327 # 4. Device description Modern Medical Electrosurgical Monopolar Forceps and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (monopolar or bipolar) to the specified output terminal of an electrosurgical generator. The forceps are intended for use with rated accessory voltage of 2.0kVp. The forceps are offered sterile (EtQ) and either as with or without smoke evacuation system which include four models, such as CD954, CD955, CD956 and CD957. Please refer it to the item 6, <Indication for use> for the detail of these four models. # 5. Intended use The device is intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical coagulation is desired during surgery and are intended to grasp, manipulate coagulate selected soft tissue. # 6. Indication for use - 6.1 Single Use Hand Switch Monopolar Forceps with Smoke Evacuation (CD954) The device delivers electrosurgical current to target tissue for coaqulation in electrosurgical procedure, with the additional function to facilitate the removal of surqical smoke generated by electrosurgery # 6.2 Single Use Hand Switch Bipolar Forceps with Smoke Evacuation (CD955) The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. # 6.3 Single Use Hand Switch Monopolar Forceps (CD956) The device delivers electrosurqical current to target tissue for coaqulation in electrosurgical procedure. - 6.4 Single Use Hand Switch Bipolar Forceps (CD957) {5}------------------------------------------------ The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure. # 7. Technological characteristics Single Use Hand Switch Forceps has substantially equivalent construction and performance as the predicate devices. # 8. Substantial Equivalence The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. ### 1. Table 1: Subject-Predicate Comparison # Proposed device: Single Use Hand Switch Monopolar Forceps with Smoke Evacuation_(CD954) | Compared Items | Proposed Device (K210315) | Predicate Device (K130669) | Predicate Device (K200372) | Result | Comments on difference/ equivalent evidence | |-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate device: K130669 and K200372 | | | | | | | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation | Olsen Medical Bipolar and Monopolar Forceps | Single Use Smoke Evacuation Fingerswitch / Pencil | | | | | Classification Name | Electrosurgic al, Cutting and Coagulation Accessories | Electrosurgic al, Cutting and Coagulation Accessories | Electrosurgic al, Cutting and Coagulation Accessories | Equivalent | | | Regulation | 878.4400 | 878.4400 | 878.4400 | Equivalent | | | Common Name | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation | Single Use Bipolar and Monopolar Forceps Multiple-Use Bipolar and Monopolar Forceps | Single Use Smoke Evacuation Fingerswitch / Pencil | Equivalent | | | Product Code | GEI | GEI | GEI | Equivalent | | | | | | | | | | Intended use | The device is intended to be used as active electrosurgica l devices where monopolar electrosurgica l coagulation is desired during surgery and are intended to grasp, manipulate coagulate selected soft tissue. | The OLSEN Medical Electrosurgic al Monopolar and Bipolar Forceps are intended to be used as active electrosurgica l devices where monopolar or bipolar electrosurgica l cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue. | Monopolar cutting and coagulation in electrosurgica l procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery . | Equivalent | Evidence: IFU | | Prescription or OTC | Prescription Use | Prescription Use | Prescription Use | Equivalent | | | Indication for use | The device delivers electrosurgica l current to target tissue for coagulation in electrosurgica l procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery . | OLSENMedic al® Electrosurgic al Monopolar and Bipolar Forceps have been designed as active electrosurgica l instruments to grasp, manipulate, cut or coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgica l cable (bipolar or monopolar) to the specified | Monopolar electrosurgica l pencil which delivers electrosurgica l current to target tissue for cutting and coagulation in electrosurgica l procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery . | Equivalent | Evidence: IFU | | | | output terminal of an electrosurgica I generator. Irradiation | | | | | Sterility | ETO | | ETO | Equivalent | ETO sterilization validation have done for this device. Evidence: EO validation report number R-EO2011 Evidence: IFU | | Usage | Single Use | Disposable and reusable | Single Use | Equivalent | Evidence: IFU | | Tip Material | Stainless Steel | Stainless Steel | Stainless Steel | Equivalent | Evidence: Material Technical Data Sheet | | Size (distal tips) | 0.1-1.2mm | 0.5-1.5mm | 0.5mm | Not Equivalent | Tip Size doesn't increase any risk for the product. Evidence: Simulation test report 956MVPE1N- 2111123R. Evidence: IFU | | Packaging | Tyvek Pouch | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU | | Electrical Safety Testing | IEC 60601-2-2 | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence: DSS_GZES2 00802563702 -IEC 60601-2-2 | | Energy delivery | Monopolar electrosurgica I Forceps which delivers electrosurgica I current to target tissue. | Monopolar or bipolar electrosurgica I Forceps which delivers electrosurgica I current to target tissue. | Monopolar electrosurgica I Forceps which delivers electrosurgica I current to target tissue. | Equivalent | Evidence: test report number 954MVPE2N- 2012196R | | Rated Accessory Voltage | 2.0kVp | The bipolar forceps are intended for use with a maximum voltage of 500 volts while the monopolar forceps have a | 4.5kVp | Equivalent | Evidence: Accelerated aging test report | | | maximum voltage of 2000 volts. | | | | | | Biocompatibili ty | Non irritant, non sensitive to skin, non toxic to cells | Non irritant, non sensitive to skin, non toxic to cells | Non irritant, non sensitive to skin, non toxic to cells | Equivalent | Evidence: Biocompatibili ty test report | | Shelf life | 3 years | 3 years | 3 years | Equivalent | Evidence: Labeling | | Target population | All patients, no specific restriction | All patients, no specific restriction | All patients, no specific restriction | Equivalent | Evidence: IFU | | Where used | Hospitals | Hospitals | Hospitals | Equivalent | Evidence: IFU | Predicate device: K130669 and K200372 {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Table 2: Subject-Predicate Comparison Proposed device: Single Use Hand Switch Bipolar Forceps with Smoke Evacuation_(CD955) # Predicate device: K032327 | Compared Items | Proposed Device (K210315) Single Use Hand Switch Bipolar Forceps with Smoke Evacuation | Predicate Device (K032327) Modern Medical Bipolar Forceps | Result | Comments on difference/ equivalent evidence | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Name | Electrosurgical, Cutting and Coagulation Accessories | Electrosurgical, Cutting and Coagulation Accessories | Equivalent | | | Regulation | 878.4400 | 878.4400 | Equivalent | | | Common Name | Single Use Hand Switch Bipolar Forceps with Smoke Evacuation | Modern Medical Bipolar Forceps | Equivalent | | | Product Code | GEI | GEI | Equivalent | | | | | | | | | Intended use | The device is intended to be used as active electrosurgical devices where bipolar electrosurgical coagulation is desired during surgery and are intended to grasp, manipulate r coagulate selected soft tissue. | The device is intended to be used as active electrosurgical devices where bipolar electrosurgical coagulation is desired during surgery and are intended to grasp, manipulate r coagulate selected soft tissue. | Equivalent | Evidence: IFU | | Prescription or OTC | Prescription Use | Prescription Use | Equivalent | | | Indication for use | The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. | The device delivers electrosurgical current to target tissue for coagulation in electrosurgical procedure, with the additional function to facilitate the removal of surgical smoke generated by electrosurgery. | Equivalent | Evidence: IFU | | Sterility | ETO | Irradiation | Equivalent | ETO sterilization validation have done for this device. Evidence: EO validation report number R-EO2011 Evidence: IFU | | Usage | Single Use | Disposable and reusable | Equivalent | Evidence: IFU | | Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence: Material Technical Data Sheet | | Size (distal tips) | 0.1-1.2mm | 0.5-2.0mm | Not equivalent | Tip Size doesn't increase any risk for the product. Evidence: | | | | | | 955MVPE1N-2111122R | | Packaging | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU | | Electrical Safety Testing | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence: DSS_GZES200802563 702-IEC 60601-2-2 | | Energy delivery | Bipolar electrosurgical Forceps which delivers electrosurgical current to target tissue. | Monopolar or bipolar electrosurgical Forceps which delivers electrosurgical current to target tissue. | Equivalent | Evidence: test report number 954MVPE2N-2012196R | | Rated Accessory Voltage | 2.0kVp | The bipolar forceps are intended for use with a maximum voltage of 500 volts while the monopolar forceps have a maximum voltage of 2000 volts. | Equivalent | Evidence: Accelerated aging test report | | Biocompatibility | Non irritant, non sensitive to skin, non toxic to cells | Non irritant, non sensitive to skin, non toxic to cells | Equivalent | Evidence: Biocompatibility test report | | Shelf life | 3 years | 3 years | Equivalent | Evidence: Labeling | | Target population | All patients, no specific restriction | All patients, no specific restriction | Equivalent | Evidence: IFU | | Where used | Hospitals | Hospitals | Equivalent | Evidence: IFU | | Functionality | With smoke evacuation | Without smoke evacuation | Not equivalent | The smoke evacuation is a features that be added to the forceps to increase convenience of functionality, without altering the intended use or risk profile (relative to a predicate) of the proposed device. Instead, smoke evacuation functionality. | | | | | | Evidence: Simulation test report. 955MVPE1N-2111121F | {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ ### Table 3: Subject-Predicate Comparison Proposed device: Single Use Hand Switch Monopolar Forceps_(CD956) Predicate device: K130669 | Compared Items | Proposed Device (K210315) Single Use Hand Switch Monopolar Forceps | Predicate Device (K130669) Olsen Medical Bipolar and Monopolar Forceps | Result | Comments on difference/ equivalent evidence | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Classification Name | Electrosurgical, Cutting and Coagulation Accessories | Electrosurgical, Cutting and Coagulation Accessories | Equivalent | | | Regulation Common Name | 878.4400 Single Use Hand Switch Monopolar Forceps | 878.4400 Single Use Bipolar and Monopolar Forceps Multiple-Use Bipolar and Monopolar Forceps | Equivalent | | | Product Code Intended use | GEI The device is intended to be used as active electrosurgical devices where monopolar electrosurgical coagulation is desired during surgery and are intended to grasp, manipulate coagulate selected soft tissue. | GEI The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue. | Equivalent | Evidence: IFU | | Prescription or OTC | Prescription Use | Prescription Use | Equivalent | | | Indication for use | | OLSENMedical® | Equivalent | Evidence: IFU | | | The device delivers electrosurgical current to target tissue for and coagulation in electrosurgical procedure. | Electrosurgical Monopolar and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate, cut or coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (bipolar or monopolar) to the specified output terminal of an electrosurgical generator. | Equivalent | | | Sterility | ETO | Irradiation | Equivalent | ETO sterilization validation have done for this device. Evidence: EO validation report number R-EO2011 Evidence: IFU | | Usage | Single Use | Disposable and reusable | Equivalent | Evidence: IFU | | Tip Material | Stainless Steel | Stainless Steel | Equivalent | Evidence: Material Technical Data Sheet | | Size (distal tips) | 0.1-1.2mm | 0.5-1.5mm | Not Equivalent | Tip Size doesn't increase any risk for the product. Evidence: Simulation test report 956MVPE1N-211 1123R. | | Packaging | Tyvek Pouch | Tyvek Pouch | Equivalent | Evidence: IFU | | Electrical Safety Testing | IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | Evidence: DSS_GZES2008 02563702-IEC 60601-2-2 | | Energy delivery | Monopolar electrosurgical Forceps which delivers electrosurgical current to target tissue. | Monopolar or bipolar electrosurgical Forceps which delivers electrosurgical current to target tissue.…

Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps