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Endoscope Reprocessor OER-PRO

by Olympus Medical Systems Corporation

510(k) K093106

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 NumberK093106 Date12 Feb 2010ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 1 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 Endoscope Reprocessor OER-PRO is a device designed for high-level disinfection of Olympus flexible endoscopes and accessories. It is manufactured by Olympus Medical Systems Corporation and is specifically engineered to provide effective reprocessing outcomes for endoscopes.

The device is supplied as a reprocessing unit for endoscopes and is intended for use in medical settings. It is authorized under FDA 510K clearance with product code FEB and is classified as a Class 2 device. The OER-PRO is designed to work with Olympus flexible endoscopes and provides a comprehensive solution for endoscope reprocessing needs.

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Questions

AI-generated answers, 1 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 Endoscope Reprocessor OER-PRO used for?

    The Endoscope Reprocessor OER-PRO is designed for high-level disinfection of Olympus flexible endoscopes and accessories, providing effective reprocessing outcomes in medical settings.

  • How is the Endoscope Reprocessor OER-PRO supplied?

    The device is supplied as a reprocessing unit specifically engineered for Olympus flexible endoscopes, providing a comprehensive solution for endoscope reprocessing needs in medical facilities.

  • What is the regulatory classification of the Endoscope Reprocessor OER-PRO?

    The OER-PRO is authorized under FDA 510K clearance with product code FEB and is classified as a Class 2 device, having received traditional clearance in 2010.

  • Which endoscopes is the OER-PRO compatible with?

    The Endoscope Reprocessor OER-PRO is specifically designed to work with Olympus flexible endoscopes and their accessories, ensuring compatibility and effective reprocessing outcomes.