510(k) K152257 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Fujifilm Duodenoscope Model ED-530XT
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Jul 21, 2017 |
| Received | Aug 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152257
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2017 | Fujifilm Medical Systems U.S.A., Inc. FUJINON ED-530XT.
This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, st Terminated |
FDT | None listed |
| Mar 9, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Endoscope
Model ED-530XT
Product Usage:
This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of Terminated |
FDT | None listed |
| Mar 9, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Endoscope
Models
ED-250XL5
ED-250XT5
ED-450XT5
ED-450XL5
Product Usage:
This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, d Terminated |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.