Navigator Flex Ureteral Access Sheath Set— 510(k) K261915
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K261915 for Navigator Flex Ureteral Access Sheath Set, Substantially Equivalent on 2026-08-04. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
Boston Scientific filed the Navigator Flex Ureteral Access Sheath Set under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology). No sizes are listed.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Boston Scientific filed from Marlborough, Massachusetts. The decision came 56 calendar days after receipt (June 9 to August 4, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Product code FED
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code FED
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code FED
product code FED- Death
- 10
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.