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ENDOSCOPE REPROCESSOR OER-Elite

by Olympus Medical Systems Corp. 2 variants

510(k) K190969

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK190969 Date9 Jul 2019ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0638-2022 FDA Class II initiated 13 Dec 2021

    The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

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  • Withdrawn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
FEB
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An endoscope reprocessor is a device used for cleaning and high-level disinfection of heat-sensitive flexible endoscopes, their accessories, and endoscope reprocessor accessories. The Endoscope Reprocessor OER-Elite is designed to provide automated cleaning and high-level disinfection for flexible endoscopes in clinical environments.

It requires an Olympus-validated detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated for efficacy and compatibility. The device is supplied as a reusable system for use in healthcare settings, with authorization under FDA 510(k) clearance (K190969) and classified as a Class II medical device under regulation number 876.1500.

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Questions

AI-generated answers, 28 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 Endoscope Reprocessor OER-Elite used for?

    The Endoscope Reprocessor OER-Elite is used for automated cleaning and high-level disinfection of heat-sensitive flexible endoscopes, their accessories, and endoscope reprocessor accessories in clinical environments.

  • How is the Endoscope Reprocessor OER-Elite supplied and is it reusable?

    The device is supplied as a reusable system designed for repeated use in healthcare settings, requiring Olympus-validated detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated for efficacy and compatibility.

  • What regulatory authorization does the Endoscope Reprocessor OER-Elite have?

    The Endoscope Reprocessor OER-Elite has FDA 510(k) clearance under K190969 and is classified as a Class II medical device under regulation number 876.1500.