510(k) K944620 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
SERIES 400 GASTROENTEROLOGY SYSTEM
| Applicant | Marks & Murase, New York NY, US |
| Decision | Substantially Equivalent, Apr 27, 1995 |
| Received | Sep 20, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944620
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals. Terminated |
FDT | None listed |
| Apr 5, 2006 | Fujinon Inc Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes. Terminated |
FDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.