510(k) K964441 ยท KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
| Applicant | Gynecare Innovation Center, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 28, 1997 |
| Received | Nov 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964441
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.