K120473 is an FDA 510(k) clearance for the PIXEL APP, a Counter, Sponge, Surgical (Class I — General Controls, product code LWH), submitted by Gauss Surgical, Inc., (Cupertino, US). The FDA issued a Cleared decision on April 9, 2012, 53 days after receiving the submission on February 16, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.2740.
| 510(k) Number | K120473 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 16, 2012 |
| Decision Date | April 09, 2012 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LWH — Counter, Sponge, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.2740 |