510(k) K120357 ยท FEB Accessories, Cleaning, For Endoscope
ENDOSCOPE REPROCESSOR OER-MINI
| Applicant | Olympus Medical Systems Corp., Center Valley PA, US |
| Decision | Substantially Equivalent, Dec 20, 2012 |
| Received | Feb 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2025 | Aizu Olympus Co., Ltd. Olympus OER-Mini Open, Classified |
FEB | None listed |
| Aug 4, 2023 | Olympus Corporation of the Americas Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories. Open, Classified |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.