K222909 is an FDA 510(k) clearance for the Axiostat Gauze. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Advamedica, Inc. (Cambridge, US). The FDA issued a Cleared decision on April 7, 2023, 193 days after receiving the submission on September 26, 2022.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K222909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | April 07, 2023 |
| Days to Decision | 193 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. |