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OVS1 Video System

by Olive Medical Corp.

510(k) K123359

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 NumberK123359 Date19 Dec 2012ClearedStatusActive

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  • Withdrawn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
FCW
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 OVS1 Video System is a fiberoptic light source device classified as a Class II medical device under FDA regulation number 876.1500. It is substantially equivalent to a predicate device and was cleared through the traditional 510(k) pathway (K123359) on December 19, 2012. The device is intended for use in gastroenterology and urology specialties as indicated by the advisory committee assignment.

The OVS1 Video System is manufactured by Olive Medical Corp. and supplied as a complete system including a processor/monitor with built-in light source, camera head with coupler, and Karl Storz fiber optic light cable. It is provided with power cords and comes with a 30-day warranty. The system is designed for portable, all-in-one use in clinical settings and includes touch-screen functionality.

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 OVS1 Video System intended for?

    The OVS1 Video System is intended for use in gastroenterology and urology specialties, as indicated by its advisory committee assignment and FDA classification under regulation number 876.1500 for fiberoptic light sources in these clinical fields.

  • How is the OVS1 Video System supplied and what components does it include?

    The OVS1 Video System is supplied as a complete all-in-one system including a processor/monitor with built-in light source, a camera head with coupler, a Karl Storz fiber optic light cable, and power cords, designed for portable use in clinical settings with touch-screen functionality.

  • Is the OVS1 Video System sterile or single-use, and what warranty does it come with?

    The OVS1 Video System is not described as sterile or single-use in the provided data; it is a reusable electronic system supplied with a 30-day warranty, indicating it is intended for multiple uses under proper maintenance and handling.