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510(k) K213231

Kerecis Silicone by Kerecis Limited — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2022
Date Received
September 30, 2021
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

  • K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (July 16, 2025)
  • K251844 — Kerecis SurgiBind (50241) (July 15, 2025)
  • K243843 — Tendon Protect (50242) (June 4, 2025)
  • K241080 — Kerecis Parvus (50207) (August 21, 2024)
  • K202430 — Kerecis Reconstruct (May 2, 2021)
  • K192612 — Kerecis Gingiva Graft (November 13, 2020)
  • K190528 — MariGen Wound Extra (July 10, 2019)
  • 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)