510(k) K221515 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Feb 2, 2023 |
| Received | May 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221515
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.