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Endoscopic CO2 Regulation Unit UCR

by Olympus Medical Systems Corporation

510(k) K081173

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 NumberK081173 Date23 Dec 2008ClearedStatusActive

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  • Withdrawn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
HET
Device class
Class II
Regulation
21 CFR Part 884.1720
Advisory committee
Obstetrics/Gynecology
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 Endoscopic CO2 Regulation Unit UCR is a medical device designed to provide intra-luminal insufflation using carbon dioxide. By utilizing CO2, the unit helps to minimize bowel distension and reduce patient discomfort during and after colonoscopy procedures.

This compact device features a one-button start/stop operation, a pressure display, and a timer function to automate CO2 insufflation shutoff. It is designed to fit on an endoscopic workstation and has received FDA 510K authorization.

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