Cleared Special

SiOxD? Wound Matrix

K241660 · Sioxmed, LLC · General & Plastic Surgery
Jul 2024
Decision
25d
Days
—
Risk

About This 510(k) Submission

K241660 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 July 5, 2024, 25 days after receiving the submission on June 10, 2024. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K241660 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2024
Decision Date July 05, 2024
Days to Decision 25 days
Submission Type Special
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.