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510(k) K241706

MicroMatrix® UBM Particulate by Acell, Inc. — Product Code KGN

K241706 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "MicroMatrix® UBM Particulate". The FDA issued a decision of Substantially Equivalent on July 11, 2024. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Acell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2024
Date Received
June 13, 2024
Clearance Type
Special
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)
  • K230980 — MicroMatrix® Flex (September 22, 2023)
  • 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

  • K260596 — Collagen Wound Powder (July 2, 2026)
  • K260669 — Endoform Dermal Template (June 24, 2026)
  • K253521 — ECMT-100 WMD (June 18, 2026)
  • K253204 — Catalyze (June 5, 2026)
  • K253974 — Roosin Collagen Dressing (June 3, 2026)
  • K254034 — Roosin Collagen Powder (June 3, 2026)
  • K261224 — MatriDerm (May 14, 2026)
  • K260532 — Derma-Gide (March 19, 2026)
  • K260218 — LacertaMatrix (February 19, 2026)
  • K253140 — CollOvine™ Wound Powder (February 10, 2026)

FDA data resources