The following data is part of a premarket notification filed by Fujifilm Medwork Gmbh with the FDA for Frog Forceps Valve (val1-f1-100).
| Device ID | K221264 |
| 510k Number | K221264 |
| Device Name: | FROG Forceps Valve (VAL1-F1-100) |
| Classification | Endoscope Channel Accessory |
| Applicant | FUJIFILM Medwork GmbH Medworkring 1 Hochstadt, DE 91315 |
| Contact | Randy Vader |
| Correspondent | Dhara Buch FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04044503035158 | K221264 | 000 |