FDA 510(k)

LithoVue Elite Digital Flexible Ureteroscope System

K-Number: K261153 · 2026-08-26

Decision Date2026-08-26

Product CodeFGB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

LithoVue Elite Digital Flexible Ureteroscope System 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 2026-08-26 under 510(k) number K261153. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LithoVue Elite Digital Flexible Ureteroscope System?

LithoVue Elite Digital Flexible Ureteroscope System is a medical device that received FDA 510(k) clearance on 2026-08-26. The listed applicant is Boston Scientific Corporation. The 510(k) number is K261153.

When did LithoVue Elite Digital Flexible Ureteroscope System receive FDA 510(k) clearance?

LithoVue Elite Digital Flexible Ureteroscope System received FDA 510(k) clearance on 2026-08-26, under 510(k) number K261153.

Who is the listed applicant for LithoVue Elite Digital Flexible Ureteroscope System?

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 LithoVue Elite Digital Flexible Ureteroscope System?

The FDA product code for LithoVue Elite Digital Flexible Ureteroscope System is FGB.

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Related Devices (Code: FGB)

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.K260013CVAC Image ProcessorCalyxo, Inc.K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)Zhejiang Geyi Medical Instrument 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.