K232847 - SiOxD Wound Matrix (FDA 510(k) Clearance)

K232847 is an FDA 510(k) clearance for the SiOxD Wound Matrix. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Sioxmed, LLC (Clemmons, US). The FDA issued a Cleared decision on December 18, 2023 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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