Atlas FDA

ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO

FDA 510(k) clearance K103264 · decided 2011-02-23

Clearance details

K-number
K103264
Device name
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
Applicant
Olympus Medical Systems Corporation
Decision
Substantially Equivalent
Date received
2010-11-04
Decision date
2011-02-23
Days to decision
111 days
Clearance type
Traditional
Product code
FEB
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Center Valley, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. recall (Z-1613-2026)Olympus Corporation of the Americas2026-03-20
Olympus OER-Pro recall (Z-0873-2026)Aizu Olympus Co., Ltd.2025-12-02
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympu recall (Z-1009-2024)Olympus Corporation of the Americas2024-02-07
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBER recall (Z-2447-2023)Olympus Corporation of the Americas2023-08-23
Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of h recall (Z-2342-2023)Olympus Corporation of the Americas2023-08-04
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector recall (Z-0138-2017)Olympus Corporation of the Americas2016-10-19