Cleared Special

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

K250517 · Boston Scientific Corporation · Gastroenterology & Urology

Mar 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K250517 is an FDA 510(k) clearance for the 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, a Endoscopic Access Overtube, Gastroenterology-urology (Class II — Special Controls, product code FED), submitted by Boston Scientific Corporation (Marlborough, US). The FDA issued a Cleared decision on March 21, 2025, 28 days after receiving the submission on February 21, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K250517 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2025
Decision Date	March 21, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FED — Endoscopic Access Overtube, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.