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510(k) K230980

MicroMatrix® Flex by Acell, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2023
Date Received
April 5, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Acell, Inc.

  • K241724 — Cytal® Wound Matrix; Cytal® Burn Matrix (July 11, 2024)
  • K241706 — MicroMatrix® UBM Particulate (July 11, 2024)
  • K191734 — MatriStem UBM Pericardial Patch (November 22, 2019)
  • K192725 — Cytal Wound Matrix 3-Layer (October 25, 2019)
  • K182259 — Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal (February 7, 2019)
  • K180776 — Cytal Wound Particulate (May 11, 2018)
  • K172399 — MicroMatrix (October 6, 2017)
  • K170763 — Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend (June 8, 2017)
  • K162554 — Gentrix Surgical Matrix (October 21, 2016)
  • K153754 — MicroMatrix (March 14, 2016)

Other clearances for product code KGN

  • K260218 — LacertaMatrix (February 19, 2026)
  • K253140 — CollOvine™ Wound Powder (February 10, 2026)
  • K251323 — Device 104 Particulate (January 22, 2026)
  • K252673 — LacertaMatrix (December 22, 2025)
  • K253339 — Theracor (December 22, 2025)
  • K250864 — MatriDerm pluS+ Bi-Layer (December 19, 2025)
  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K250397 — Helios Dermal Scaffold (August 15, 2025)
  • K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (July 16, 2025)