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510(k) K190528

MariGen Wound Extra by Kerecis Limited — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2019
Date Received
March 4, 2019
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 Kerecis Limited

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  • K243843 — Tendon Protect (50242) (June 4, 2025)
  • K241080 — Kerecis Parvus (50207) (August 21, 2024)
  • K213231 — Kerecis Silicone (June 29, 2022)
  • K202430 — Kerecis Reconstruct (May 2, 2021)
  • K192612 — Kerecis Gingiva Graft (November 13, 2020)
  • K153364 — Kerecis SecureMesh (August 19, 2016)
  • K132343 — MARIGEN WOUND DRESSING (October 23, 2013)

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)