Cleared Traditional

K261915 - Navigator™ Flex Ureteral Access Sheath Set

K261915 is an FDA 510(k) clearance for Navigator Flex Ureteral Access Sheath Set, manufactured by Boston Scientific Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K261915 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
56d
Days
Class 2
Risk

K261915 is an FDA 510(k) clearance for the Navigator™ Flex Ureteral Access Sheath Set. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlborough, US). The FDA issued a Cleared decision on August 4, 2026 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

FDA 510(k) Submission Details - K261915

510(k) Number K261915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2026
Decision Date August 04, 2026
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 131d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FED Device Classification - Class 2, Special Controls

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FED Endoscopic Access Overtube, Gastroenterology-urology

All 82
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K261915.
CVAC Aspiration System
K260965 · Calyxo, Inc. · Apr 2026
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
K260521 · Zhuhai Pusen Medical Technology Co., Ltd. · Apr 2026
Prodeon Urethral Sheath System
K252572 · Prodeon Medical, Inc. · Oct 2025
Single Use Suction-Evacuation Ureteral Access Sheath
K250128 · Anhui Happiness Workshop Medical Instruments Co., Ltd. · Sep 2025
Ureteral Access Sheath
K250132 · Zhejiang Yigao Medical Technology Co., Ltd. · Sep 2025
Single-use Ureteral Access Sheath
K250695 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Jul 2025