Home / 510(k) Clearances / K140510

510(k) K140510

MIROMATRIX WOUND MATRIX by Miromatrix Medical, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2014
Date Received
February 28, 2014
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 Miromatrix Medical, Inc.

  • K162570 — Miromatrix Biological Mesh TW (February 16, 2017)
  • K160400 — Miromatrix Biological Mesh (June 8, 2016)
  • K150341 — Miromatrix Biological Mesh RS (May 12, 2015)
  • K143426 — Wound Matrix TF (January 27, 2015)
  • K134033 — MIROMATRIX BIOLOGICAL MESH (March 31, 2014)

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)