K163507 is an FDA 510(k) clearance for the Triton Sponge System, a Image Processing Device For Estimation Of External Blood Loss (Class II — Special Controls, product code PBZ), submitted by Gauss Surgical, Inc., (Los Altos, US). The FDA issued a Cleared decision on April 25, 2017, 132 days after receiving the submission on December 14, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.2750.
| 510(k) Number | K163507 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 14, 2016 |
| Decision Date | April 25, 2017 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PBZ — Image Processing Device For Estimation Of External Blood Loss |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2750 |
| Definition | An Image Processing Device For Estimation Of External Blood Loss Is A Device To Be Used As An Aid In Estimation Of Patient External Blood Loss. The Device May Include Software And/or Hardware That Is Used To Process Images Capturing Externally Lost Blood To Estimate The Hemoglobin Mass And/or The Blood Volume Present In The Images. |