510(k) K103264 ยท FEB Accessories, Cleaning, For Endoscope
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Feb 23, 2011 |
| Received | Nov 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103264
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. Open, Classified |
FEB | None listed |
| Dec 2, 2025 | Aizu Olympus Co., Ltd. Olympus OER-Pro Open, Classified |
FEB | None listed |
| Feb 7, 2024 | Olympus Corporation of the Americas Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water.
The MAJ-2318 water filter is compatible Open, Classified |
FEB | None listed |
| Aug 23, 2023 | Olympus Corporation of the Americas The Air/Water Valve is provided/used with the following Endoscopes:
ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE:
GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, G Open, Classified |
FEB | None listed |
| Aug 4, 2023 | Olympus Corporation of the Americas Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories. Open, Classified |
FEB | None listed |
| Oct 19, 2016 | Olympus Corporation of the Americas OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector Terminated |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.