510(k) K944759 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
| Applicant | Fujinon, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Apr 11, 1995 |
| Received | Sep 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-250XL5 Operations Manual: Cleaning, Disinfection Terminated |
FDT | None listed |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-250XT5
Operations Manual: Cleaning Disinfection and Storage Terminated |
FDT | None listed |
| Sep 22, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures. Terminated |
FET | None listed |
| Sep 22, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure).
For use in endoscopic procedures. Used to observe, record and capture images. Terminated |
FET | None listed |
| Aug 31, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. Terminated |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.