SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) (K262386): 510(k) cleared Oct 20, 2026

SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000)

Stryker Instruments · Oct 20, 2026 · K262386

FDA cleared the SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) from Stryker Instruments on Oct 20, 2026 under K262386, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 13, 2026. The decision came 99 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Instruments has 5 other decisions in the tracker over the last 12 months: K262244 (Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)), K261959 (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)), K261544 (Hydro Irrigation System), K253679 (Hydro Irrigation System).

Questions & Answers

What did FDA clear under K262386?

K262386 is the FDA 510(k) for SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000), submitted by Stryker Instruments. FDA's decision date was Oct 20, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000)?

Stryker Instruments, based in Portage, MI, is the applicant of record for K262386.

How long did the K262386 review take?

FDA received the submission on Jul 13, 2026 and issued its decision on Oct 20, 2026, 99 days later.

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