510(k) K243532 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
LumiRex Ureteroscope
| Applicant | Contra Healthcare Solutions, LLC, Butler PA, US |
| Decision | Substantially Equivalent, Apr 28, 2025 |
| Received | Nov 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243532
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.