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510(k) K213498

PELNAC Meshed Bilayer Wound Matrix by Gunze Limited — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2022
Date Received
November 1, 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 Gunze Limited

  • K221487 — NEOVEIL Staple Line Reinforcement (August 26, 2022)
  • K213573 — PELNAC Wound Matrix (February 9, 2022)
  • K191992 — PELNAC Bilayer Wound Matrix (April 29, 2020)
  • K130997 — NEOVEIL (November 15, 2013)

Other clearances for product code KGN

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  • 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)