510(k) K100275 ยท FAS Electrode, Electrosurgical, Active, Urological
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
| Applicant | Olympus Winter & Ibe GmbH, Center Valley PA, US |
| Decision | Substantially Equivalent, Jul 1, 2010 |
| Received | Feb 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100275
| 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.