510(k) K220587 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, May 11, 2022 |
| Received | Mar 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220587
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2026 | Olympus Corporation of the Americas Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the in Open, Classified |
FDT | None listed |
| Jun 5, 2025 | Olympus Corporation of the Americas Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V Open, Classified |
NWB | None listed |
| Feb 9, 2024 | Olympus Corporation of the Americas Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V-
designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around t Open, Classified |
FDT | None listed |
| 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.