510(k) K233630 · FGB Ureteroscope And Accessories, Flexible/Rigid
Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Jun 24, 2024 |
| Received | Nov 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233630
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.