Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 17, 2026 Stryker Instruments Jessica Brophy Staff Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002 Re: K261959 Trade/Device Name: Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 11, 2026 Received: June 11, 2026 Dear Jessica Brophy: 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: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261959 - Jessica Brophy Page 2 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, 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. {2} K261959 - Jessica Brophy Page 3 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 (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, # Colin K. Chen -S Digitally signed by Colin K. Chen -S Date: 2026.09.17 21:33:19 -04'00' Colin K. 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 {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. | K261959 | ? | | Please provide the device trade name(s). | | ? | | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100); Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102); Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100); Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | | | | Please provide your Indications for Use below. | | ? | | The Neptune SafeAir Pencils are designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect. The indications for use are unchanged from K160693. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} 510(k) Summary K261959 stryker ## 510(k) Summary ### Submitter Information This premarket Notification is submitted by: **Table 1 – Submitter Information** | **This Premarket Notification is submitted by: 510(k) Owner** | Stryker Instruments 1941 Stryker Way Portage, MI 49002 USA | | --- | --- | | **Contact Person** | Jessica Brophy Staff Regulatory Affairs Specialist | | **Registration Number** | 3015967359 | | **Date Summary Prepared** | March 18 2026 | ### Device Name **Table 2 – Subject Device Information** | **Trade/Proprietary Name** | Neptune SafeAir | | --- | --- | | **Regulation Name** | Electrosurgical cutting and coagulation device and accessories | | **Review Panel** | General & Plastic Surgery | | **Product Code** | GEI | | **Regulatory Class** | Class II | ### Predicate Device The legally marketed predicate for the subject device is detailed in Table 3. **Table 3 – Predicate Device Information** | Predicate Device Name | 510(k) | Product Code | Manufacturer | | --- | --- | --- | --- | | Neptune E-SEP Pencils | K160693 | GEI | Stryker Instruments | Page 1 of 5 {5} 510(k) Summary stryker ## Device Description The Neptune SafeAir Pencils are single use, radiofrequency (RF) monopolar devices, designed to be used in electrosurgical applications for cutting and coagulation. The Pencils are designed to also facilitate the removal of smoke generated by electrosurgery when used with an effective smoke evacuation system. ## Indications for Use The Neptune SafeAir Pencil is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect ## Contraindications Do not use monopolar electrosurgery on small appendages, as in circumcision or finger surgery ## Substantial Equivalence Comparison The predicate device has been identified as the Neptune E-SEP pencils (K160693). Both the subject and predicate device share the same intended use, and indications for use and similar technological characteristics. The subject device introduces a new pencil variation for a pencil with coated electrode and squared edge tip. Results of verification and validation demonstrate that these differences do not introduce new questions of safety and effectiveness. The subject devices are at least as safe and effective as the predicate device. Page 2 of 5 {6} 510(k) Summary stryker **Table 4 – Intended Use Comparison** | Description | Subject | Predicate | | --- | --- | --- | | | Neptune SafeAir Pencils | Neptune E-SEP Pencils (K160693) | | **Classification** | Class II | Class II | | **Regulation** | 21 CFR 878.4400 Electrosurgical cutting and coagulation device and accessories. | 21 CFR 878.4400 Electrosurgical cutting and coagulation device and accessories. | | **Product Code** | GEI | GEI | | **Indications for Use** | The Neptune SafeAir Pencil is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect | The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect | | **Type of Use** | Rx Only | Rx Only | | **Conditions of Use** | Single Use | Single Use | | **Contraindications** | Do not use monopolar electrosurgery on small appendages, as in circumcision or finger surgery | Do not use monopolar electrosurgery on small appendages, as in circumcision or finger surgery | Page 3 of 5 {7} 510(k) Summary stryker **Table 5 – Technological Characteristics Comparison** | Description | Subject | Predicate | | --- | --- | --- | | | Neptune SafeAir Pencils | Neptune E-SEP Pencils (K160693) | | **Energy Type** | RF Monopolar Energy | RF Monopolar Energy | | **Power Supply** | Monopolar generator supplied by user | Monopolar generator supplied by user | | **Voltage Rating** | Maximum 5.5 kV peak | Maximum 5.5 kV peak | | **Electrical Connector** | US-3-Pin | US-3-Pin | | **Electrical Safety Testing** | IEC 60601-1 IEC 60601-2-2 | IEC 60601-1 IEC 60601-2-2 | | **Sterilization** | Sterile, Single use (EtO)* **For Sterile part numbers only* | Sterile, Single use (EtO) | | **Electrode Rod Diameter** | 2.4 mm (3/32 inches) | 2.4 mm (3/32 inches) | | **Electrode Connector Feature** | Pentagonal | Pentagonal | | **Electrode Material** | Coated Stainless Steel | Coated Stainless Steel | | **Electrode Length** | 70 mm | 70 mm | | **Adjustable Suction Sleeve** | Yes | Yes | | **Evacuation Tubing Dimension** | 10 mm diameter x 3 m length | 10 mm diameter x 3 m length | | **Smoke Evacuation System Connector** | 8mm, 22mm | 8mm, 22mm | | **Handpiece Dimension** | 15mm Diameter x 190 mm Length | 15mm Diameter x 190 mm Length | | **Operation Function Switches** | CUT button labelled yellow and proximal to electrode COAG button labelled blue and distal to electrode | CUT button labelled yellow and proximal to electrode COAG button labelled blue and distal to electrode | ### Summary of Non-Clinical Testing The following tests were conducted to demonstrate substantial equivalence with the predicate device: - Sterilization Testing Page 4 of 5 {8} 510(k) Summary stryker - Functional/Performance Testing - Biocompatibility Testing - Thermal Spread Testing - Packaging Testing - Electrical Safety and EMC Testing Testing requirements were determined by relevant standards and FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, issued March 9, 2020. ### **Performance Testing** A range of design verification testing was conducted to confirm the subject devices perform as intended and are safe and effective for their intended use in accordance with FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, issued March 9, 2020. ### **Summary of Clinical Testing** Clinical testing was not required for this Special 510(k). ### **Conclusion** The subject devices, in comparison with the legally marketed predicate, share the same intended use and operating principles. Performance testing demonstrate that the subject devices are at least as safe and effective as the predicate. Any differences between the subject and predicate devices do not raise any new or different types of questions of safety and effectiveness. A determination of substantial equivalence is supported. Page 5 of 5