510(k) K171965 ยท FAS Electrode, Electrosurgical, Active, Urological
Resection Electrodes with HF cable
| Applicant | Olympus Winter & Ibe GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Sep 28, 2017 |
| Received | Jun 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171965
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2022 | Olympus Corporation of the Americas HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S Open, Classified |
FJL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.