510(k) K152092 ยท FAS Electrode, Electrosurgical, Active, Urological
Resection Electrodes
| Applicant | Olympus Winter & Ibe GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Oct 26, 2015 |
| Received | Jul 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152092
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2023 | Olympus Corporation of the Americas HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications.
64 Models:
1) A22201C
2) A222 Open, Classified |
FAS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.