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FDA 510(k)

Navigator™ Flex Ureteral Access Sheath Set

K-Number: K261915 · 2026-08-04

ApplicantBoston Scientific Corporation
Decision Date2026-08-04
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Navigator™ Flex Ureteral Access Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-08-04 under 510(k) number K261915. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navigator™ Flex Ureteral Access Sheath Set?

Navigator™ Flex Ureteral Access Sheath Set is a medical device that received FDA 510(k) clearance on 2026-08-04. The listed applicant is Boston Scientific Corporation. The 510(k) number is K261915.

When did Navigator™ Flex Ureteral Access Sheath Set receive FDA 510(k) clearance?

Navigator™ Flex Ureteral Access Sheath Set received FDA 510(k) clearance on 2026-08-04, under 510(k) number K261915.

Who is the listed applicant for Navigator™ Flex Ureteral Access Sheath Set?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Navigator™ Flex Ureteral Access Sheath Set?

The FDA product code for Navigator™ Flex Ureteral Access Sheath Set is FED.

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Other records listing Boston Scientific Corporation as applicant

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Related Devices (Code: FED)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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