510(k) K190969 ยท FEB Accessories, Cleaning, For Endoscope
ENDOSCOPE REPROCESSOR OER-Elite
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jul 9, 2019 |
| Received | Apr 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190969
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.