510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161067Substantially Equivalent

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

Engineered Tissue Solutions, LLC, Rolla MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161067 is the FDA 510(k) clearance record for Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”, cleared for Engineered Tissue Solutions, LLC on under FDA product code QSZ (Absorbable Synthetic Wound Dressing). FDA's definition for product code QSZ reads: "Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application". FDA records list one 510(k) clearance for Engineered Tissue Solutions, LLC. As of , FDA records show no recalls naming K161067.

Clearance record

Decision date
Received
(153 days to decision)
Product code
QSZ Absorbable Synthetic Wound Dressing
Device class
Unclassified
Review panel
Unknown
Applicant
Engineered Tissue Solutions, LLC 4030 Hypoint N., Rolla MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSZ

Trailing 12 months
3 clearances under product code QSZ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QSZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260