K222189 is an FDA 510(k) clearance for the SiOxD Wound Matrix. This device is classified as a Absorbable Synthetic Wound Dressing.
Submitted by Sioxmed, LLC (Clemmons, US). The FDA issued a Cleared decision on November 18, 2022, 119 days after receiving the submission on July 22, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application..
| 510(k) Number | K222189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2022 |
| Decision Date | November 18, 2022 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSZ - Absorbable Synthetic Wound Dressing |
| Device Class | - |
| Definition | Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application. |