510(k) K201920 ยท FEB Accessories, Cleaning, For Endoscope
Endoscope Reprocessor OER-Elite
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Sep 1, 2020 |
| Received | Jul 10, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201920
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110.
May be included with the Olympus OER-ELITE. Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115. Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. Open, Classified |
FEB | None listed |
| Apr 22, 2026 | Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. Open, Classified |
FEB | None listed |
| Mar 20, 2026 | Olympus Corporation of the Americas Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. Open, Classified |
FEB | None listed |
| Dec 2, 2025 | Aizu Olympus Co., Ltd. Olympus OER-Elite Open, Classified |
FEB | None listed |
| Aug 4, 2023 | Olympus Corporation of the Americas Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories. Open, Classified |
FEB | None listed |
| Dec 13, 2021 | Olympus Corporation of the Americas OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories Terminated |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.