Cleared Traditional

SiOxD Wound Matrix

K232847 · Sioxmed, LLC · General & Plastic Surgery
Dec 2023
Decision
95d
Days
Risk

About This 510(k) Submission

K232847 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 December 18, 2023, 95 days after receiving the submission on September 14, 2023. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K232847 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2023
Decision Date December 18, 2023
Days to Decision 95 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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.