510(k) K853585 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
| Applicant | Olympus Corp., Lake Success NY, US |
| Decision | Substantially Equivalent, Jan 21, 1986 |
| Received | Aug 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2018 | Olympus Corporation of the Americas Olympus JF-140F duodenoscopes (Model NumberJF-140F) Terminated |
FET | None listed |
| May 11, 2018 | Olympus Corporation of the Americas Olympus JF-160F duodenoscopes (Model NumberJF-160F) Terminated |
FET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.