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510(k) K161067

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” by Engineered Tissue Solutions, LLC — Product Code QSZ

K161067 is an FDA 510(k) premarket notification submitted by Engineered Tissue Solutions, LLC for the device "Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”". The FDA issued a decision of Substantially Equivalent on September 15, 2016. The device falls under product code QSZ (Absorbable Synthetic Wound Dressing), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2016
Date Received
April 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorbable Synthetic Wound Dressing
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.

Other clearances for product code QSZ

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  • K251567 — NovoSorb BTM (June 20, 2025)
  • K242149 — NovoSorb® MTX (March 5, 2025)
  • K241660 — SiOxD® Wound Matrix (July 5, 2024)
  • K232847 — SiOxD Wound Matrix (December 18, 2023)
  • K223725 — Restrata® MiniMatrix (May 18, 2023)
  • K222189 — SiOxD Wound Matrix (November 18, 2022)
  • K221686 — NovoSorb Matrix (September 15, 2022)
  • K193583 — Restrata® (September 25, 2020)
  • K173544 — Phoenix Wound Matrix (March 2, 2018)

FDA data resources