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Battery Powered Endosccopic Light Source

by Mitsubishi Cable America, Inc.

510(k) K960081

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960081 Date12 Mar 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FCQ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Battery Powered Endoscopic Light Source is an incandescent diagnostic light source designed for use with endoscopes in gastroenterology and urology procedures. It provides illumination to enable visual assessment during diagnostic endoscopic examinations.

The device is supplied as a battery‑operated unit intended for connection to diagnostic endoscopes. It was cleared by the FDA through a traditional 510(k) submission (K960081) and is classified as a Class II device (product code FCQ). The source is a single‑use, non‑sterile accessory that operates without external power cords, and it is regulated under 21 CFR 876.1500 for gastrointestinal and urological applications.

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