The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Distal Cap Model Dh-32en, Distal Cap Model Dh-17en2.
| Device ID | K212296 |
| 510k Number | K212296 |
| Device Name: | Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 |
| 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 | 2021-07-22 |
| Decision Date | 2021-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410458442 | K212296 | 000 |
| 04547410450071 | K212296 | 000 |