510(k) K232911 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
| Applicant | Karl Storz Endovision, Inc., Charlton MA, US |
| Decision | Substantially Equivalent, Jun 10, 2024 |
| Received | Sep 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232911
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.