510(k) K202661 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Dec 8, 2020 |
| Received | Sep 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2023 | Olympus Corporation of the Americas EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V Open, Classified |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.