K213413 is an FDA 510(k) clearance for the Hemostatic Dressing. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Jiangsu Newvalue Medical Products Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on September 1, 2023, 682 days after receiving the submission on October 19, 2021.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K213413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2021 |
| Decision Date | September 01, 2023 |
| Days to Decision | 682 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. |