510(k) K253905 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
PrimeSight UltraView System
| Applicant | Cogentix Medical, Inc., Orangeburg NY, US |
| Decision | Substantially Equivalent, Apr 7, 2026 |
| Received | Dec 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253905
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.