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OTV-S5 OES Video System

by Olympus America, Inc.

510(k) K955404

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 NumberK955404 Date1 Feb 1996ClearedStatusActive

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  • Withdrawn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, 26 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 OTV-S5 OES Video System is a video camera system designed for use with rigid and fiberoptic scopes. It is a substantially equivalent device cleared through the FDA 510(k) process under product code GCJ.

The system is supplied as a reusable device intended for use in gastroenterology and urology settings. It includes features such as an S-video zoom lens, built-in digitally enhanced fiber filter, and beamsplitter Gyn coupler. The device was cleared on February 1, 1996, under K955404 and is manufactured by Olympus America, Inc.

Other devices from Olympus America, Inc.

See all devices from Olympus America, Inc. →

Questions

AI-generated answers, 26 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 OTV-S5 OES Video System used for?

    The OTV-S5 OES Video System is designed for use with rigid and fiberoptic scopes in gastroenterology and urology settings, providing video imaging support during endoscopic procedures.

  • Is the OTV-S5 OES Video System reusable or single-use?

    The OTV-S5 OES Video System is supplied as a reusable device, meaning it can be cleaned and reused multiple times following appropriate reprocessing protocols, as indicated in its FDA 510(k) clearance.

  • What are the key features of the OTV-S5 OES Video System?

    The system includes an S-video zoom lens, a built-in digitally enhanced fiber filter, and a beamsplitter Gyn coupler, which together enhance image quality and compatibility with various endoscopic scopes.

  • How was the OTV-S5 OES Video System cleared for market?

    The OTV-S5 OES Video System was cleared as substantially equivalent through the FDA 510(k) process under K955404, with product code GCJ, based on its intended use and technological characteristics.

  • Who manufactures the OTV-S5 OES Video System and where is it located?

    The OTV-S5 OES Video System is manufactured by Olympus America, Inc., located at Two Corporate Center Dr., Melville, NY 11747, United States.