K143462 is an FDA 510(k) clearance for the AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use). This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Benq Materials Corporation (Taoyuan, TW). The FDA issued a Cleared decision on May 8, 2015, 155 days after receiving the submission on December 4, 2014.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K143462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2014 |
| Decision Date | May 08, 2015 |
| Days to Decision | 155 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. |