K170213 - SupraSDRM Biodegradable Matrix Wound Dressing (FDA 510(k) Clearance)

K170213 is an FDA 510(k) clearance for the SupraSDRM Biodegradable Matrix Wound Dressing. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Polymedics Innovations, GmbH (Denkendorf, DE). The FDA issued a Cleared decision on June 28, 2017 after a review of 155 days - an extended review cycle.

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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