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The Tracker / August 2026 / K261915

510(k) cleared

Navigator Flex Ureteral Access Sheath Set

Boston Scientific Corporation · Aug 4, 2026 · K261915

FDA cleared the Navigator Flex Ureteral Access Sheath Set from Boston Scientific Corporation on Aug 4, 2026 under K261915, a traditional 510(k). The device falls under product code FED, Endoscopic Access Overtube, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 9, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific Corporation has 8 other decisions in the tracker over the last 12 months: K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K253692 (AVVIGO+ Multi-Modality Guidance System), K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261488 (OBSIDIO Conformable Embolic).

Questions & Answers

What did FDA clear under K261915?

K261915 is the FDA 510(k) for Navigator Flex Ureteral Access Sheath Set, submitted by Boston Scientific Corporation. FDA's decision date was Aug 4, 2026, under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology).

Who makes the Navigator Flex Ureteral Access Sheath Set?

Boston Scientific Corporation, based in Marlborough, MA, is the applicant of record for K261915.

How long did the K261915 review take?

FDA received the submission on Jun 9, 2026 and issued its decision on Aug 4, 2026, 56 days later.

← All decisions in August 2026