510(k) clearance
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)
- 510(k) number
- K261959
- Applicant
- Stryker Instruments
- Decision date
- Sep 17, 2026
- Date received
- Jun 11, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- GEI
- Device type
- Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II
- Regulation
- 21 CFR 878.4400
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Portage, MI, US