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Fiber Optic Light Transmission Cable

by Opto Vision, Inc.

510(k) K892145

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 NumberK892145 Date29 Sep 1989ClearedStatusActive

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  • Withdrawn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
FFS
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.

Fiber Optic Light Transmission Cable is a device used for image illumination in endoscopic procedures. It is designed to transmit light through optical fibers to provide illumination during gastroenterology and urology endoscopy.

The device is supplied as a reusable cable and is classified as a Class II medical device under FDA regulation number 876.1500. It received traditional 510(k) clearance (K892145) on September 29, 1989, and is substantially equivalent to a predicate device. No information regarding sterility, single-use status, MRI safety, specific sizes, or storage conditions is provided in the data.

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