510(k) K042076 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
| Applicant | Fujinon, Inc., Huntington CT, US |
| Decision | Substantially Equivalent, Nov 18, 2004 |
| Received | Aug 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope; ED-530XT Operation Manual
'Operation and Preparation' and 'Cleaning, Disinfection and Storage' Terminated |
FDT | None listed |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-450XT5
Operation Manual: Cleaning, Disinfection and Storage Terminated |
FDT | None listed |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-450XL5
Operation Manual: Cleaning, Disinfection and Storage Terminated |
FDT | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.