510(k) K250517 · FED Endoscopic Access Overtube, Gastroenterology-Urology
Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD U
| Applicant | Boston Scientific Corporation, Marlborough MA, US |
| Decision | Substantially Equivalent, Mar 21, 2025 |
| Received | Feb 21, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250517
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.