Cleared Traditional

K090160 - SUPRATHEL WOUND AND BURN DRESSING

K090160 · Polymedics Innovations, GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - QSZ Absorbable Synthetic Wound Dressing

All 20
Devices cleared under the same product code (QSZ) and FDA review panel - the closest regulatory comparables to K090160.
Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
K161067 · Engineered Tissue Solutions, LLC · Sep 2016
BTM Wound Dressing
K142879 · Polynovo Biomaterials Pty, Ltd. · Dec 2015
GORE BIO-A WOUND MATRIX
K132397 · W.L. Gore & Associates, Inc. · May 2014
HYALOMATRIX PA
K073251 · Fidia Advanced Biopolymers Srl · Dec 2007
TOPKIN WOUND DRESSING
K031684 · Biomet Merck GmbH · Oct 2003
K090160 · SUPRATHEL WOUND AND BURN DRESSING
Download PDF FDA Summary Polymedics Innovation…