Navigator Flex Ureteral Access Sheath Set— 510(k) K261915

Name: FDA 510(k) clearance K261915
Creator: U.S. Food and Drug Administration
Published: 2026-08-04

Substantially Equivalent

Boston 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.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-06-09
Decision date: 2026-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FED

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K260965 — CVAC Aspiration System2026-04-13
K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)2026-04-06
K252572 — Prodeon Urethral Sheath System2025-10-07
K250128 — Single Use Suction-Evacuation Ureteral Access Sheath2025-09-19
K250132 — Ureteral Access Sheath2025-09-05

More clearances from Boston Scientific Corporation

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K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
K261488 — OBSIDIO Conformable Embolic2026-07-24
K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24
K262462 — TheraSphere 360 Y-90 Management Platform2026-07-24
K261978 — WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System2026-07-10

Adverse events under product code FED

product code FED

Death: 10
Total: 10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.