Cleared Traditional

K161067 - Mirragen Advanced Wound Matrix

K161067 · Engineered Tissue Solutions, LLC · General & Plastic Surgery device
Download Printable Device Report (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.

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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
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.