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510(k) K231152

Collagen Wound Dressing by Winner Medical Co., Ltd. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2023
Date Received
April 24, 2023
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 Winner Medical Co., Ltd.

  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
  • K231057 — Antibacterial Gel Wound Dressing (December 1, 2023)
  • K231564 — Skin and Wound Cleanser (November 10, 2023)
  • K221311 — Antibacterial Bandage (June 21, 2023)
  • K223232 — Procedure mask/Surgical mask/Face mask (March 6, 2023)
  • K221532 — PHMB Wound Dressing (January 30, 2023)
  • K221754 — Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone A (January 17, 2023)
  • K221755 — Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimi (January 13, 2023)
  • K221720 — Extra Silver Gelling Fiber Dressing (December 21, 2022)

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)