The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Duodenoscope Model Ed-530xt.
| Device ID | K152257 |
| 510k Number | K152257 |
| Device Name: | Fujifilm Duodenoscope Model ED-530XT |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Contact | Aaron Ge |
| Correspondent | John J Smith HOGAN LOVELLS US LLP 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-10 |
| Decision Date | 2017-07-21 |
| Summary: | summary |