510(k) K261915 · FED Endoscopic Access Overtube, Gastroenterology-Urology
Navigator Flex Ureteral Access Sheath Set
| Applicant | Boston Scientific Corporation, Marlborough MA, US |
| Decision | Substantially Equivalent, Aug 4, 2026 |
| Received | Jun 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261915
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.