Cleared Traditional

K090160 - SUPRATHEL WOUND AND BURN DRESSING

K090160 · Polymedics Innovations, GmbH · General & Plastic Surgery device
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May 2009
Decision
118d
Days
-
Risk

K090160 is an FDA 510(k) clearance for the SUPRATHEL WOUND AND BURN DRESSING. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Polymedics Innovations, GmbH (Denkendorf, DE). The FDA issued a Cleared decision on May 20, 2009 after a review of 118 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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FDA 510(k) Submission Details - K090160

510(k) Number K090160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2009
Decision Date May 20, 2009
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
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.