510(k) K143153 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jan 15, 2016 |
| Received | Nov 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143153
| 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 |
| Dec 10, 2021 | Olympus Corporation of the Americas EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V
Model Number: TJF-Q180V Open, Classified |
FDT | None listed |
| Dec 17, 2018 | Olympus Corporation of the Americas Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. Terminated |
NWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.