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StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection

by Boston Scientific

510(k) K233645

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233645↗

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 · Special NumberK233645 Date12 Dec 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3188-2026 FDA Class II initiated 22 Jul 2026

    A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.

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  • Withdrawn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 StoneSmart Connect Console, LithoVue Elite Standard Deflection, and LithoVue Elite Reverse Deflection are flexible ureteroscopes designed for visualizing and treating urinary stones. These devices fall under the category of ureteroscopes and accessories, enabling minimally invasive procedures to access and manage renal or ureteral calculi with enhanced deflection capabilities for precise navigation.

These devices are intended for use in gastroenterology and urology settings and are supplied as single-use systems. The console integrates with a digital flexible ureteroscope, providing real-time imaging and intrarenal pressure monitoring. Authorized under FDA 510K and MDR, they are classified as Class II medical devices and are regulated under 21 CFR 876.1500. Storage and handling follow standard sterile single-use protocols.

Other devices from Boston Scientific

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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 clinical specialties are these devices primarily intended for, and how do they support procedures in those fields?

    The StoneSmart Connect Console and LithoVue Elite ureteroscopes (both Standard and Reverse Deflection) are designed for use in gastroenterology and urology settings. They enable minimally invasive procedures to visualize and treat urinary stones (renal or ureteral calculi) by providing enhanced deflection capabilities for precise navigation within the urinary tract. The console integrates with a digital flexible ureteroscope to offer real-time imaging and intrarenal pressure monitoring, which aids clinicians in safely and effectively accessing and managing stones.

  • Are these devices single-use or reusable, and what does that mean for storage and handling?

    These devices are single-use systems, meaning they are intended for one-time use only. As single-use items, they must be stored according to sterile single-use protocols to ensure safety and efficacy. This includes maintaining proper packaging integrity, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions (e.g., temperature, humidity). Reuse is not recommended or supported.

  • What are the key differences between the LithoVue Elite Standard Deflection and Reverse Deflection models?

    The LithoVue Elite Standard Deflection and Reverse Deflection models are both flexible ureteroscopes, but their primary distinction lies in their deflection capabilities. Standard Deflection provides forward and side-to-side bending, while Reverse Deflection offers additional flexibility in the opposite direction, allowing for more precise navigation in complex anatomical pathways. This can be particularly useful for accessing stones in challenging locations within the urinary tract.

  • How are these devices regulated, and what does that mean for purchasing or using them in clinical practice?

    These devices are regulated under FDA 510K clearance and the EU Medical Device Regulation (MDR), classifying them as Class II medical devices in the U.S. under 21 CFR 876.1500. This means they undergo rigorous review to ensure safety and effectiveness before market authorization. For purchasing or clinical use, this implies compliance with regulatory requirements, including proper training, adherence to manufacturer instructions, and adherence to sterile single-use protocols. The regulatory route ensures these devices meet established standards for ureteroscopes and accessories.