510(k) K252703 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
| Applicant | Boston Scientific Corporation, Marlborough MA, US |
| Decision | Substantially Equivalent, Sep 24, 2025 |
| Received | Aug 27, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252703
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.