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Flexible Video-Uretero-Renoscope System

by Karl Storz Endoscopy-America, Inc. 2 variants

510(k) K131369

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK131369 Date26 Nov 2013ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1068-2022 FDA Class II initiated 1 Apr 2022

    Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

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  • Withdrawn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, 19 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 Flexible Video-Uretero-Renoscope System is a flexible ureteroscope and accessories designed for endoscopic visualization of the urinary tract, including the kidney and ureter. It provides real-time imaging for diagnostic and therapeutic procedures within the upper urinary system, enabling minimally invasive interventions such as stone removal, biopsy, or obstruction relief.

This system is intended for single-use applications in urological settings, supplied sterile and compatible with compatible camera systems. It is classified as a Class II medical device under FDA regulations (K131369) and includes multiple model-specific accessories for instrumentation. The device adheres to MRI safety standards for non-ferromagnetic components and requires proper storage in a clean, dry environment to maintain sterility and functionality.

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Questions

AI-generated answers, 19 Sep 2026

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

  • Is this device designed for reuse or is it intended for single-use only in clinical settings?

    The Flexible Video-Uretero-Renoscope System is explicitly designed for single-use applications in urological procedures. It is supplied sterile and intended to be discarded after one use, ensuring patient safety and reducing the risk of cross-contamination.

  • What types of procedures can this device be used for within the urinary tract?

    This system is intended for endoscopic visualization of the urinary tract, including the kidney and ureter, enabling minimally invasive procedures such as stone removal, biopsy, or obstruction relief. It provides real-time imaging to guide therapeutic interventions in the upper urinary system.

  • How should this device be stored to maintain its sterility and functionality?

    The device must be stored in a clean, dry environment to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, proper storage conditions are critical to prevent contamination before use.

  • Does this device have any special considerations for MRI compatibility?

    Yes, the Flexible Video-Uretero-Renoscope System adheres to MRI safety standards for non-ferromagnetic components. This ensures it can be safely used in clinical settings where MRI imaging may be required, reducing the risk of interference or injury during procedures.

  • What regulatory pathway was followed for this device’s approval, and which advisory committee reviewed it?

    The device was cleared through the FDA’s 510(k) Traditional pathway, with a Substantially Equivalent (SESE) determination. It was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its dual relevance to both specialties.