ClearanceBrief
510(k) K250327 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories

OptaBlate Radiofrequency (RF) Generator System

ApplicantStryker Instruments, Portage MI, US
DecisionSubstantially Equivalent, Apr 15, 2025
ReceivedFeb 5, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K250327

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.