K240097 is an FDA 510(k) clearance for the Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5), a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Ushare Medical, Inc. (Zhuhai, CN). The FDA issued a Cleared decision on May 22, 2024, 131 days after receiving the submission on January 12, 2024. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K240097 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 12, 2024 |
| Decision Date | May 22, 2024 |
| Days to Decision | 131 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. |