K123387 is an FDA 510(k) clearance for the QUIKCLOT HEMOSTATIC DRESSING. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Z-Medica, LLC (Wallingford, US). The FDA issued a Cleared decision on April 12, 2013, 161 days after receiving the submission on November 2, 2012.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K123387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2012 |
| Decision Date | April 12, 2013 |
| Days to Decision | 161 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. |