510(k) K222189
K222189 is an FDA 510(k) premarket notification submitted by Sioxmed, LLC for the device "SiOxD Wound Matrix". The FDA issued a decision of Substantially Equivalent on November 18, 2022. The device falls under product code QSZ (Absorbable Synthetic Wound Dressing), a Class U device. Sioxmed, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2022
- Date Received
- July 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Synthetic Wound Dressing
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.