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Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

by Richard Wolf Medical Instruments Corporation

510(k) K183188

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK183188 Date3 May 2019ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 25 Sep 2026

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

Flexible Sensor-Ureterorenoscopes BOA Vision EF and Flexible Sensor-Ureterorenoscopes COBRA Vision EF are ureteroscopes and accessories, flexible/rigid, used for visualizing body cavities and organs via natural and surgically created passages. These devices are intended for use by specialized medical personnel who are medically qualified and adequately instructed.

The devices are supplied for examination, diagnostics, and clinical application in urological treatments. They are used by trained professionals in clinical settings and are not described as sterile, single-use, reusable, MRI safe, or having specific storage conditions in the provided data. Authorization is based on FDA 510(k) clearance under K183188, with product code FGB and regulation number 876.1500.

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Questions

AI-generated answers, 25 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 is the intended use of the Flexible Sensor-Ureterorenoscopes BOA Vision EF and COBRA Vision EF?

    These devices are intended for visualizing body cavities and organs via natural and surgically created passages, specifically for examination, diagnostics, and clinical application in urological treatments by specialized medical personnel who are medically qualified and adequately instructed.

  • Are the Flexible Sensor-Ureterorenoscopes BOA Vision EF and COBRA Vision EF supplied as sterile or single-use devices?

    The provided data does not describe these devices as sterile, single-use, or reusable; therefore, no information about sterility or single-use status is available from the authorization details.

  • What regulatory pathway was used for the authorization of the Flexible Sensor-Ureterorenoscopes BOA Vision EF and COBRA Vision EF?

    Authorization is based on FDA 510(k) clearance under K183188, with product code FGB and regulation number 876.1500, indicating a traditional 510(k) submission found substantially equivalent to a predicate device.