The following data is part of a premarket notification filed by Jdi Surgical, Inc. with the FDA for E-brik Visualization Assistant.
| Device ID | K221293 |
| 510k Number | K221293 |
| Device Name: | E-Brik Visualization Assistant |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | JDI Surgical, Inc. 9925 Silver Maple Way Highlands Ranch, CO 80129 |
| Contact | Dwight Lenox |
| Correspondent | Srividya Pothana University Of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City, UT 84112 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-04 |
| Decision Date | 2022-07-07 |