The following data is part of a premarket notification filed by Gauss Surgical, Inc. with the FDA for Pixel App.
| Device ID | K121274 |
| 510k Number | K121274 |
| Device Name: | PIXEL APP |
| Classification | Counter, Sponge, Surgical |
| Applicant | GAUSS SURGICAL, INC. 22700 ALCALDE RD Cupertino, CA 95014 |
| Contact | Peggy Mclaughlin |
| Correspondent | Peggy Mclaughlin GAUSS SURGICAL, INC. 22700 ALCALDE RD Cupertino, CA 95014 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-27 |
| Decision Date | 2012-06-27 |