K172324 is an FDA 510(k) clearance for the Axiostat Chitosan Hemostatic Dressing. 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 February 23, 2018, 206 days after receiving the submission on August 1, 2017.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K172324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2017 |
| Decision Date | February 23, 2018 |
| Days to Decision | 206 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. |