The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Duodenoscope Model Ed-580xt.
| Device ID | K191747 |
| 510k Number | K191747 |
| Device Name: | FUJIFILM Duodenoscope Model ED-580XT |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Kamila Sak FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2019-09-27 |
| Summary: | summary |