510(k) K251867 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Sep 19, 2025 |
| Received | Jun 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2025 | Olympus Corporation of the Americas Brand Name: EVIS EXERA III Duodenovideoscope
Product Name: Olympus TJF-Q190V
Model/Catalog Number: TJF-Q190V
Product Description: This instrument is intended to be used with an Olympus video system ce Open, Classified |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.