K202830 is an FDA 510(k) clearance for the Axiostat Patch. 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 15, 2021, 202 days after receiving the submission on September 25, 2020.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K202830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2020 |
| Decision Date | April 15, 2021 |
| Days to Decision | 202 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. |