510(k) K250269 · FAJ Cystoscope And Accessories, Flexible/Rigid
Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Jun 11, 2025 |
| Received | Jan 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250269
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.