510(k) K253226 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
UV5000W Handle
| Applicant | Uroviu Corporation, Los Altos CA, US |
| Decision | Substantially Equivalent, Oct 23, 2025 |
| Received | Sep 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253226
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.