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Chakoff Endoscopy Light Source Endoscopic Xenon Arc

by Stephen Chakoff, Inc.

510(k) K950747

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 NumberK950747 Date6 Mar 1995ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The Chakoff Endoscopy Light Source Endoscopic Xenon Arc is a medical device designed to provide illumination for endoscopic procedures. It utilizes xenon arc technology to generate the light required for visualization during clinical examinations.

This device is identified under FDA 510(k) clearance K950747 and is classified as a laparoscope for use in general and plastic surgery. It is manufactured by Stephen Chakoff, Inc. and is subject to the regulatory requirements associated with its product code GCJ.

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Questions

AI-generated answers, 6 Oct 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 primary clinical use of the Chakoff Endoscopy Light Source?

    The Chakoff Endoscopy Light Source is designed to provide illumination for endoscopic procedures, specifically for visualization during clinical examinations in general and plastic surgery.

  • What technology does the Chakoff Endoscopy Light Source use for illumination?

    This device utilizes xenon arc technology to generate the necessary light for endoscopic visualization, ensuring consistent illumination during surgical procedures.

  • What is the regulatory status of the Chakoff Endoscopy Light Source?

    The device is identified under FDA 510(k) clearance K950747 and is classified under product code GCJ, indicating it has been found substantially equivalent to predicate devices for its intended use in general and plastic surgery.