510(k) K233645 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
| Applicant | Boston Scientific Corporation -, Marlborough MA, US |
| Decision | Substantially Equivalent, Dec 12, 2023 |
| Received | Nov 14, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233645
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Boston Scientific Corporation Boston Scientific Corporation
StoneSmart Connect Console
Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable
REF: M0067933000, M006793300H0, M006793 Open, Classified |
FGB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.