Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 8, 2026 Zhejiang Geyi Medical Instrument Co., Ltd. Cathy Tan Director, Regulatory Affairs # 1, 2 Factory, # 5, Hutang Rd. Xiaya Town Jiande City, Zhejiang 311606 CHINA Re: K254294 Trade/Device Name: Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: August 9, 2026 Received: August 10, 2026 Dear Cathy Tan: We have reviewed your 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 (the 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 available 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: The Center for Devices and Radiological Health (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 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254294 - Cathy Tan Page 2 Federal Regulations, Title 21, Parts 800 to 898. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn {2} K254294 - Cathy Tan Page 3 (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-devices/device-advice-comprehensive-regulatory-assistance/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, Reginald K. Avery -S for Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254294 | ? | | Please provide the device trade name(s). | | ? | | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A 12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12, GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15- 22, GYUT-B 15- 30) | | | | Please provide your Indications for Use below. | | ? | | This Single-use Digital Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. It can only be used with Geyi Medical endoscope camera system GY-AIO-121. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K254294 Page 1 of 10 # 510(k) SUMMARY 510(k) Number:K254294 ## I. SUBMITTER Name: Zhejiang Geyi Medical Instrument Co., LTD. Address: No.1,2 Factory,No.5 hutang Road, Xiaya, Jiande City, 311606, Zhejiang Province.P.R.China Name of contact person: Cathy Tan Tel:+86-15158157854 Fax: +86-15158157854 E-mail:lilyxu@zjgeyi.com Date prepared: September 7, 2026 ## II. Proposed Device Submission Number: K254294 Trade/Device Name: Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A 12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12, GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15- 22, GYUT-B 15- 30) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulation class: II Review Panel: Obstetrics/Gynecology Product code: HIH ## III. Predicate Device 510(k) number: K240978 Device name: SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) Applicant: MacroLux Medical Technology Co., Ltd. Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories {5} K254294 Page 2 of 10 Regulation class: II Review Panel: Obstetrics/Gynecology Product code: HIH Note: This predicate device has not been subject to a design-related recall. #### IV. Reference Device 510(k) number: K232003 Device name: Single-Use Video Hysteroscope: RP-G-C24, RP-G-C0101 Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd. Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulation class: II Review Panel: Obstetrics/Gynecology Product code: HIH Note: This reference device has not been subject to a design-related recall. #### V. Indications for use This Single-use Digital Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. It can only be used with Geyi Medical endoscope camera system, GY-AIO-121. #### VI. Description of the Device The Single-use Digital Hysteroscope consists of three main parts: an operation section with a connecting cable, water irrigation and suction tube section and insertion section with a rigid insertion tube. The head of the insertion section integrates an LED light source, a 400*400 pixel (GYUT-A) or 1280*720-pixel (GYUT-B) CMOS image sensor and an instrument channel tube with an inner diameter of 2.15 mm, 2.35 mm, or 1.95 mm. During use, the LED light source provides illumination, the CMOS image sensor captures the image pixels of the tissue area, and the instrument channel tube serves as a passage for biopsy forceps, scissor forceps, foreign body forceps. The operation section is equipped with two function shortcut keys corresponding to the preset functions of the endoscope camera host. Pressing the key, the host will have the corresponding function. The water irrigation and suction tube is connected to the corresponding irrigation tubing/suction tubing of the fluid management system. The water irrigation tube provides a pathway for irrigation fluid to the distal end of the hysteroscope, while the suction tube {6} K254294 Page 3 of 10 provides a pathway for removal of fluids from the surgical site through the fluid management system. The plug at the tail end of the connecting cable is connected to the handle extension cable to transmit the image pixels obtained by the image sensor to the host, thereby achieving the surgical imaging function. It is ethylene oxide (EO) sterilized. It's single use only. There are twelve models of the Single-Use Video Hysteroscope. The models are identical except for the width of insertion port, Bending Angle, and diameter of instrument channel, as shown in the table below: | Models | Maximum insertion portion width | Minimum instrument channel diameter | Bending Angle | Working length | | --- | --- | --- | --- | --- | | GYUT-A 12.6-0 | 4.5mm | 2.15mm | 0° | 220mm±10mm | | GYUT-A 12.6-12 | 4.5mm | 2.15mm | 12°±5° | 220mm±10mm | | GYUT-A 12.6-22 | 4.5mm | 2.15mm | 22°±5° | 220mm±10mm | | GYUT-A 12.6-30 | 4.5mm | 2.15mm | 30°±5° | 220mm±10mm | | GYUT-A 14.4-0 | 5.1mm | 2.35mm | 0° | 220mm±10mm | | GYUT-A 14.4-12 | 5.1mm | 2.35mm | 12°±5° | 220mm±10mm | | GYUT-A 14.4-22 | 5.1mm | 2.35mm | 22°±5° | 220mm±10mm | | GYUT-A 14.4-30 | 5.1mm | 2.35mm | 30°±5° | 220mm±10mm | | GYUT-B 15-0 | 5.3mm | 1.95mm | 0° | 220mm±10mm | | GYUT-B 15-12 | 5.3mm | 1.95mm | 12°±5° | 220mm±10mm | | GYUT-B 15-22 | 5.3mm | 1.95mm | 22°±5° | 220mm±10mm | | GYUT-B 15-30 | 5.3mm | 1.95mm | 30°±5° | 220mm±10mm | The materials used in construction of the insertion portion of Hysteroscope are Polyether block polyamide(PEBAX), Stainless steel, polyimide(PI), Silicone gel and Acrylonitrile Butadiene Styrene(ABS). The materials used in construction of the water irrigation and suction portion of Hysteroscope are Thermoplastic polyurethane rubber(TPU), Polycarbonate(PC). The handle does not contact the patient. {7} K254294 Page 4 of 10 ## VII. Comparison with the Predicate Device ### Comparison of Indications with the Predicate Device The indications for use are the same for the predicate device. ### Comparison of Technological Characteristics with the Predicate Device Subjective device and the predicate device have the same intended use. The subject and predicate device have similar technological characteristics as evidenced by the table below. All differences have been discussed in detail and concluded that these differences in technological characteristics do not raise new questions regarding safety or effectiveness of the subject device. a. The following basic technological elements are the same or similar for the subject and predicate device | Item | Subject DeviceSingle-use Digital Hysteroscope | Predicate deviceSeleneView®Single-Use Digital Hysteroscope(HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | Discussion | | --- | --- | --- | --- | | 510(k) number | K254294 | K240978 | | | Classification Product Code | HIH | HIH | same | {8} K254294 Page 5 of 10 | Indications for use | Single-use Digital Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. | The SeleneView® (model: HC29, HC29-G, HC35,HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. | Same | | --- | --- | --- | --- | | Route of Advancement | Advanced to uterine cavity via the cervical canal | Advanced to cervical canal and uterine cavity | Same | | Site of use | Hospitals and physician offices | SeleneView® is intended for use in professional healthcare facility environments such as hospitals and clinics. SeleneView® is designed for use in adults. | Same | | Components | The hysteroscope system is composed of Single-use Digital Hysteroscope and endoscopic video image processor. | SeleneView®Single-Use Digital Hysteroscope consists of a handle, insertion portion and endoscope cable. The SeleneView® is intended to be used combined with ViewHub® Video Processor to perform its intended function and the ViewHub® has been 510(k) cleared in K233779. | Same | {9} K254294 Page 6 of 10 | Cannula Outer Diameter | GYUT-A 12.6- 0/ GYUT-A 12.6- 12/GYUT-A 12.6- 22/ GYUT-A 12.6- 30: 4.5mm. GYUT-A 14.4- 0/ GYUT-A 14.4- 12/GYUT-A 14.4- 22/ GYUT-A 14.4- 30: 5.1mm. GYUT-B 15-0/GYUT-B 15-12/ GYUT-B 15-22/GYUT-B 15-30: 5.3mm. | HC29/HC29-G: 2.9mm HC35/HC35-G: 3.85mm HO35/HO35-G: 3.8mm HO42/HO42-G: 4.3mm | Different 1 | | --- | --- | --- | --- | | Minimum instrument diameter | GYUT-A 12.6- 0/ GYUT-A 12.6- 12/GYUT-A 12.6- 22/ GYUT-A 12.6- 30: 2.15mm. GYUT-A 14.4- 0/ GYUT-A 14.4- 12/GYUT-A 14.4- 22/ GYUT-A 14.4- 30: 2.35mm. GYUT-B 15-0/GYUT-B 15-12/ GYUT-B 15-22/GYUT-B 15-30: 1.95mm. | HC29/HC29-G: none HC35/HC35-G: none HO35/HO35-G: ≥1.8mm HO42/HO42-G: ≥2.0mm | Different 2 | | --- | --- | --- | --- | | Cannula Total Length | 220mm±10mm | 220 mm | Same | | Illumination light source | LED | LED | Same | | Image transmission | Images captured by the CMOS chip at the distal end are transmitted through the endoscopes and the video processor to the user. | The images are transmitted through the endoscope with a CMOS image module at the distal end and video processor. | Same | | Optical Image | CMOS | CMOS | Same | {10} K254294 Page 7 of 10 | Sterilization | The Single-use Digital Hysteroscope is sterile following exposure to ethylene oxide (EO) | The Hysteroscope is sterile after sterilization with ethylene oxide (EO) | Same | | --- | --- | --- | --- | | Tissue contact materials | Compliant with ISO 10993 | Compliant with ISO 10993 | Same | | Field of View | GYUT-A 12.6- 0/ GYUT-A 12.6- 12/ GYUT-A 12.6- 22/ GYUT-A 12.6- 30/GYUT-A 14.4- 0/ GYUT-A 14.4- 12/GYUT-A 14.4- 22/ GYUT-A 14.4- 30: 120°. GYUT-B 15-0/GYUT-B 15- 12/GYUT-B 15- 22/ GYUT-B 15- 30: 140°. | HC29/HC29-G/HO35/HO35-G: 120° HC35/HC35-G/HO42/HO42-G: 140° | Same | | Depth of field | GYUT-A 12.6- 0/ GYUT-A 12.6- 12/GYUT-A 12.6- 22/ GYUT-A 12.6- 30/GYUT-A 14.4- 0/ GYUT-A 14.4- 12/GYUT-A 14.4- 22/ GYUT-A 14.4- 30: 3-50mm. GYUT-B 15-0/GYUT-B 15- 12/GYUT-B 15- 22/ GYUT-B 15-30: 3-100mm. | 3mm~100mm | same | | Direction of view | 0° | 15° | Different 3 | | Image Resolution | GYUT-A 12.6- 0,GYUT-A 12.6- 12/GYUT-A 12.6- 22, GYUT-A 12.6- 30,GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30: 400*400 pixels GYUT-B 15-0/GYUT-B-12/GYUT-B 15-22/GYUT-B 15-30: 1280*720 pixels | HC29/HC29-G/HO35/HO35-G: 400*400 pixels HC35/HC35-G/HO42/HO42-G: 1280*720 pixels | Same | {11} K254294 Page 8 of 10 **b. Discussion on differences between the subject and the predicate device** Differences 1, 2 and 3 between the subject and predicate device include differences in outer diameter, minimum instrument channel diameter and direction of view are minor and do not raise different questions of safety and effectiveness. Differences have been evaluated through performance testing. **VIII. Summary of Non-clinical Performance** **Performance testing** Mechanical testing was performed on the proposed device and included the following: - Appearance - Maximum insert section width - Minimum Working channel width - Working length - Bending Angle - Water Supply System - Water Supply System sealing performance - Performance of Flow Regulator in Water Supply System - Suction system - Suction system sealing performance - Performance of Flow Regulator in suction System - Tensile strength - Luer connector - Handle plug attachment force test - Handle plug detachment force test Comparative testing related to image quality parameters including the following list was performed for the proposed device and the predicate and reference devices to support substantial equivalence - Color performance - Field of view (FOV) {12} K254294 Page 9 of 10 - Direction of view (DOV) - Uniformity - Depth of field (DOF) - Resolution - Distortion - Signal-to-noise ratio (SNR) - Dynamic range ### Electrical safety and electromagnetic compatibility (EMC) Electrical Safety and EMC data include in the submission meet the following standards. - IEC60601-1:2012, and AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 - IEC 60601-2-18:2009: Part 2-18 - IEC 60601-1-2:2014 and A1:2020 ### Biocompatibility Biocompatibility evaluation of the Single-use Digital Hysteroscope was conducted in accordance with the FDA Guidance document “Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process”. The device is considered to contact a breached or compromised surface for a duration of less than 24 hours. The following biocompatibility studies were conducted on the final, finished, EO sterilized device and in accordance with the GLP requirements: cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity and pyrogenicity. All evaluation acceptance criteria were met. ### Photobiological safety The optical performance include following items: The LEDs in the proposed device were tested according to IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems. {13} K254294 Page 10 of 10 ### Sterilization Validation and Shelf Life The sterilization method has been validated to ISO 11135:2014, which has thereby determined the routine control and monitoring parameters. The Single-use Digital Hysteroscope is sterilized with EO to a sterility level of SAL 10⁻⁶, and EO/ECH residual tests were performed according to ISO 10993-7:2008. Shelf life is determined based on stability studies which includes ageing test according to ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and simulated shipping distribution test according to ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems. Samples were subjected to accelerated aging and simulated shipping distribution to evaluate the package integrity and device performance throughout the labeled shelf life. ### IX. Substantially Equivalent (SE) Conclusion Performance testing presented in this premarket notification demonstrated that the proposed devices are substantially equivalent to the predicate device.