Cleared Traditional

K170213 - SupraSDRM Biodegradable Matrix Wound Dr...

K170213 · Polymedics Innovations, GmbH · General & Plastic Surgery device
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Jun 2017
Decision
155d
Days
-
Risk

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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FDA 510(k) Submission Details - K170213

510(k) Number K170213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2017
Decision Date June 28, 2017
Days to Decision 155 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 115d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

QSZ Device Classification - Class 0,

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.