510(k) K233275 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)
| Applicant | Gyrus Acmi, Inc., Brooklyn Park MN, US |
| Decision | Substantially Equivalent, Mar 25, 2024 |
| Received | Sep 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233275
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.