K250517
- 510(k) number
- K250517
- Device name
- 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 Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2025-03-21
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K250517.pdf
Official FDA record: K250517
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.