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Karl Storz 495N Series Fiber Optic Light Cables

by Karl Storz Endoscopy-America, Inc.

510(k) K931018

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 NumberK931018 Date25 Jun 1993ClearedStatusActive

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  • Withdrawn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
GCJ
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 Karl Storz 495N Series Fiber Optic Light Cables are fiber optic light sources designed for endoscopic procedures. These cables transmit illumination from external light sources to endoscopic instruments, ensuring optimal visibility during examinations and interventions in gastroenterology and urology.

These cables are supplied in various lengths (230 cm, 300 cm, and 7.5 ft) with a consistent 3.5 mm diameter fiber bundle. They are autoclavable, indicating they are reusable after sterilization, and are compatible with Karl Storz light sources and endoscopes. The device holds an FDA 510(k) clearance under the product code GCJ, with a decision date of June 25, 1993.

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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.

  • Are these light cables meant for single-use or can they be reused after sterilization?

    These cables are designed for reuse. The manufacturer explicitly states they are autoclavable, meaning they can be sterilized in an autoclave and used multiple times, provided proper cleaning and sterilization protocols are followed.

  • What lengths and diameter are available for the Karl Storz 495N Series Fiber Optic Light Cables?

    The cables come in three lengths: 230 cm, 300 cm, and 7.5 ft. All models share a consistent 3.5 mm diameter fiber bundle, ensuring compatibility with Karl Storz endoscopes and light sources.

  • Which types of procedures are these light cables intended to support?

    These cables are designed for gastroenterology and urology procedures. They transmit illumination to endoscopic instruments, ensuring clear visibility during examinations and interventions in those specialties.

  • How do I know if these cables are compatible with my existing Karl Storz equipment?

    The cables are explicitly compatible with Karl Storz light sources and endoscopes, meaning they should work with standard Karl Storz systems. However, verify your specific model’s connector type and light source compatibility to ensure seamless integration.

  • What regulatory pathway was followed for FDA clearance of these light cables?

    The device received FDA 510(k) clearance under product code GCJ with a decision date of June 25, 1993. The submission was reviewed by the Gastroenterology and Urology (GU) Advisory Committee and determined to be substantially equivalent to a predicate device.