K222189 is an FDA 510(k) clearance for the SiOxD Wound Matrix, 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 review panel.
| 510(k) Number | K222189 FDA.gov |
| FDA Decision | Cleared 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. |