510(k) K193182 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, Jan 17, 2020 |
| Received | Nov 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193182
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other
ancillary equipment for endoscopy and endoscopic surgery
Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V. Open, Classified |
FET | None listed |
| Aug 28, 2023 | Olympus Corporation of the Americas EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V Open, Classified |
FDT | None listed |
| May 19, 2023 | Olympus Corporation of the Americas Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100 Open, Classified |
FDT | None listed |
| Jan 28, 2021 | Olympus Corporation of the Americas Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps Terminated |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.