510(k) K080403 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
XTJF TYPE Q160VF1
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, May 20, 2008 |
| Received | Feb 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2016 | Olympus Corporation of the Americas Olympus TJF-Q180V flexible gastrointestinal Duodenoscope
Product Usage:
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monito Terminated |
FDT | None listed |
| Sep 22, 2015 | Olympus America Inc. EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V.
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy Terminated |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.