510(k) clearance
SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000)
- 510(k) number
- K262386
- Applicant
- Stryker Instruments
- Decision date
- Oct 20, 2026
- Date received
- Jul 13, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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