K232250 is an FDA 510(k) clearance for the SurgiCount+ System. This device is classified as a Image Processing Device For Estimation Of External Blood Loss (Class II - Special Controls, product code PBZ).
Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on January 11, 2024, 167 days after receiving the submission on July 28, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.2750. 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..
| 510(k) Number | K232250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2023 |
| Decision Date | January 11, 2024 |
| Days to Decision | 167 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. |