ClearanceBrief
510(k) K262386 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories

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

ApplicantStryker Instruments, Portage MI, US
DecisionSubstantially Equivalent, Oct 20, 2026
ReceivedJul 13, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K262386

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.