FDA 510(k)

LithoVue Elite Digital Flexible Ureteroscope System

Número K: K261153 · 2026-08-26

Data da decisão2026-08-26

Código do produtoFGB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Dispositivos Relacionados (Código: FGB)

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.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.

Fonte oficial

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