510(k) K250797 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
UV5000 Handle
| Applicant | Uroviu Corporation, Los Altos CA, US |
| Decision | Substantially Equivalent, Sep 11, 2025 |
| Received | Mar 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250797
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.