The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Distal Cap Models 33-40.
| Device ID | K193123 |
| 510k Number | K193123 |
| Device Name: | FUJIFILM Distal Cap Models 33-40 |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2019-12-11 |