510(k) K200369 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
OES Elite Ureteroscopes and Accessories
| Applicant | Olympus Winter & Ibe GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Aug 28, 2020 |
| Received | Feb 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200369
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.