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LithoVue System

by Boston Scientific

510(k) K153049

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153049↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK153049 Date13 Nov 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FGB
FDA applicant
Boston Scientific Corporation
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LithoVue System is a flexible and rigid ureteroscope and its associated accessories, designed for visualisation and intervention within the urinary tract. It is classified as a Class II medical device and is intended for diagnostic and therapeutic procedures, including lithotripsy and stone retrieval in the ureter and kidney.

The system is supplied as a reusable device, with components that may require sterilisation before use. It is intended for use in MRI-unsafe environments and is available in various sizes and configurations as indicated by the listed FEI numbers. Authorisations include FDA 510K clearance under the Traditional pathway and compliance with the MDR. The device is regulated under the product code FGB and regulation number 876.1500.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of procedures is the LithoVue System designed for within the urinary tract?

    The LithoVue System is specifically designed for diagnostic and therapeutic procedures in the urinary tract, including lithotripsy (stone fragmentation) and stone retrieval in the ureter and kidney. It combines flexible and rigid ureteroscopes with associated accessories to provide visualization and intervention capabilities.

  • Is the LithoVue System reusable, and if so, how should it be prepared for use?

    Yes, the LithoVue System is a reusable device. Components intended for reuse must be properly sterilized before each use to ensure safety and efficacy, as outlined in the manufacturer’s instructions.

  • What sizes and configurations are available for the LithoVue System, and how can I identify them?

    The LithoVue System is available in multiple sizes and configurations, each identified by unique FEI numbers (e.g., 3015139943, 3025349506, etc.). These numbers correspond to specific models and working lengths, allowing for selection based on clinical needs such as ureteral or renal access.

  • Can the LithoVue System be used in an MRI environment, and if not, why?

    No, the LithoVue System is explicitly intended for use in MRI-unsafe environments. This is due to the presence of materials or components that could pose a risk if exposed to MRI fields, such as potential heating or mechanical failure.

  • What regulatory pathways does the LithoVue System follow, and how does this affect its use?

    The LithoVue System has received FDA 510K clearance under the Traditional pathway and complies with the EU Medical Device Regulation (MDR). This means it has undergone premarket review for safety and effectiveness, ensuring it meets regulatory standards for diagnostic and therapeutic use in the urinary tract. The product code FGB and regulation number 876.1500 further categorize its classification as a Class II device.