K261915
- 510(k) number
- K261915
- Device name
- Navigator Flex Ureteral Access Sheath Set
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2026-08-04
- Date received
- 2026-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261915.pdf
Official FDA record: K261915
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.