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StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring

by Boston Scientific

510(k) K221515

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) K221515↗

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 NumberK221515 Date2 Feb 2023ClearedStatusActive
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  • Withdrawn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 Elite Single Use Digital Flexible Ureteroscope is a flexible ureteroscope designed for minimally invasive visualization and treatment of urinary tract stones. It combines digital imaging technology with flexible navigation to enable precise stone identification, fragmentation, and retrieval within the ureter or renal collecting system.

This device is supplied as a single-use, sterile, disposable system intended for use in urological procedures. It includes pressure monitoring capabilities to support safe and controlled navigation, and is compatible with MRI environments as indicated by its regulatory classification. The device is authorized under FDA 510K and MDR, with a classification as a Class II medical device under the 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 urinary tract procedures is the LithoVue Elite Single Use Digital Flexible Ureteroscope designed for?

    The LithoVue Elite Single Use Digital Flexible Ureteroscope is specifically designed for minimally invasive visualization and treatment of urinary tract stones within the ureter or renal collecting system. Its flexible design and digital imaging technology enable precise identification, fragmentation, and retrieval of stones during urological procedures.

  • Is the LithoVue Elite Single Use Digital Flexible Ureteroscope reusable or single-use, and how does this affect its sterility?

    The LithoVue Elite Single Use Digital Flexible Ureteroscope is supplied as a single-use, sterile, disposable system. This design ensures sterility is maintained for each procedure, eliminating the need for reprocessing and reducing the risk of cross-contamination between patients.

  • Does this device include pressure monitoring, and why is this feature important?

    Yes, the LithoVue Elite Single Use Digital Flexible Ureteroscope comes with pressure monitoring capabilities. This feature supports safe and controlled navigation during procedures, helping to minimize the risk of complications such as ureteral perforation or vascular injury by providing real-time feedback on pressure levels.

  • Are there different models of the LithoVue Elite Single Use Digital Flexible Ureteroscope, and if so, what distinguishes them?

    Yes, there are two primary models: the Standard and the Reverse versions. While both are single-use, digital, and flexible ureteroscopes with pressure monitoring, the key distinction lies in their design orientation—likely optimized for different anatomical approaches or procedural preferences in urological stone management.

  • How should the LithoVue Elite Single Use Digital Flexible Ureteroscope be stored, and what considerations should be taken into account?

    Since the device is single-use and sterile, it should be stored in its original packaging in a clean, dry environment protected from extreme temperatures and direct sunlight. The packaging ensures sterility is preserved until use, so it should remain unopened until the procedure begins. Compatibility with MRI environments is noted in its regulatory classification, but storage should still follow manufacturer guidelines to maintain functionality.