K160578 is an FDA 510(k) clearance for the Nustat XR. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.
Submitted by Beeken Biomedical, LLC (Stoughton, US). The FDA issued a Cleared decision on June 29, 2016, 120 days after receiving the submission on March 1, 2016.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K160578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2016 |
| Decision Date | June 29, 2016 |
| Days to Decision | 120 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. |