510(k) K261153 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
LithoVue Elite Digital Flexible Ureteroscope System
| Applicant | Boston Scientific Corporation, Marlborough MA, US |
| Decision | Substantially Equivalent, Aug 26, 2026 |
| Received | Apr 8, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261153
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.