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Karl Storz Cutting Loop Electrodes Modification

by Karl Storz Endoscopy-America, Inc.

510(k) K934647

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 closed

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 NumberK934647 Date9 Feb 1994ClearedStatusActive

Recalls

12 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-1314-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1308-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1316-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1315-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1307-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1305-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1313-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1306-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1312-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1310-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1309-2013 FDA Class II initiated 1 Jun 2009
    • Terminated Z-1311-2013 FDA Class II initiated 1 Jun 2009

    Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

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  • Withdrawn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
FJL
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

This device is a resectoscope cutting loop electrode modification, classified as a Class II medical device under product code FJL and regulation number 876.1500. It is designed for use in gastroenterology and urology procedures, specifically as part of a resectoscope system for tissue cutting during endoscopic resection.

The device received FDA 510(k) clearance K934647 on February 9, 1994, following a traditional submission process. It is manufactured by Karl Storz Endoscopy-America, Inc. in Culver City, California, and is supplied as a non-sterile, reusable electrode component intended for use with compatible resectoscope systems. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.

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Questions

AI-generated answers, 28 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 Karl Storz Cutting Loop Electrodes Modification used for?

    It is designed for use in gastroenterology and urology procedures as part of a resectoscope system to cut tissue during endoscopic resection, based on its classification under product code FJL and regulation 876.1500.

  • Is the Karl Storz Cutting Loop Electrodes Modification sterile or single-use?

    The device is supplied as a non-sterile, reusable electrode component, meaning it is intended for multiple uses after appropriate cleaning and sterilization by the healthcare facility, as no single-use or sterile status is indicated in the data.

  • How was the Karl Storz Cutting Loop Electrodes Modification cleared for market?

    It received FDA 510(k) clearance K934647 on February 9, 1994, through a traditional submission process, demonstrating substantial equivalence to a legally marketed predicate device.