K213652 is an FDA 510(k) clearance for the Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG). This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Cresilon, Inc. (Brooklyn, US). The FDA issued a Cleared decision on June 28, 2023, 586 days after receiving the submission on November 19, 2021.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K213652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2021 |
| Decision Date | June 28, 2023 |
| Days to Decision | 586 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSY - Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device Class | - |
| Definition | To Temporarily Control Bleeding And Cover External Wounds. |