Cleared Traditional

K161067 - Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”

K161067 · Engineered Tissue Solutions, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
153d
Days
-
Risk

K161067 is an FDA 510(k) clearance for the Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, M.... Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Engineered Tissue Solutions, LLC (Rolla, US). The FDA issued a Cleared decision on September 15, 2016 after a review of 153 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.

FDA 510(k) Submission Details - K161067

510(k) Number K161067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2016
Decision Date September 15, 2016
Days to Decision 153 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
38d slower than avg
Panel avg: 115d · This submission: 153d
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 Consultant

Hogan Lovells US LLP
Randy Prebula

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K161067.
NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)
K172140 · Polynovo Biomaterials Pty, Ltd. · Aug 2017
SupraSDRM Biodegradable Matrix Wound Dressing
K170213 · Polymedics Innovations, GmbH · Jun 2017
Restrata Wound Matrix
K170300 · Acera Surgical, Inc. · Apr 2017
BTM Wound Dressing
K142879 · Polynovo Biomaterials Pty, Ltd. · Dec 2015
GORE BIO-A WOUND MATRIX
K132397 · W.L. Gore & Associates, Inc. · May 2014
SUPRATHEL WOUND AND BURN DRESSING
K090160 · Polymedics Innovations, GmbH · May 2009
K161067 · Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
Download PDF FDA Summary Engineered Tissue Sol…