FDA 510(k)

LithoVue Elite Digital Flexible Ureteroscope System

N.º K: K261153 · 2026-08-26

SolicitanteBoston Scientific Corporation

Fecha de decisión2026-08-26

Código de productoFGB

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Boston Scientific Corporation como solicitante

K262151SpaceOAR Flex™ System K261915Navigator™ Flex Ureteral Access Sheath Set K262165FARADRIVE™ Steerable Sheath (M004PF21M402)K262462TheraSphere 360™ Y-90 Management Platform K261488OBSIDIO Conformable Embolic K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

Ver todos los 167 dispositivos →

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.