510(k) K904939 ยท EZO Urethrotome
FLEXIBLE AND RIGID URETEROTOME SYSTEM
| Applicant | Olympus Corp., Lake Success NY, US |
| Decision | Substantially Equivalent, Jan 7, 1992 |
| Received | Nov 1, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904939
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2011 | Olympus America Inc. OLYMPUS Pediatric Knives and Resection Electrodes
The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral Terminated |
EZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.