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510(k) K253974

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2026
Date Received
December 11, 2025
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 Roosin Medical Co., Ltd.

  • K254034 — Roosin Collagen Powder (June 3, 2026)
  • K231088 — Copper Foam Dressing (Prescription and OTC) (January 11, 2024)
  • K230190 — Polyver Silver Alginate Dressing (Prescription and OTC) (November 17, 2023)
  • K181478 — Roosin Xeroform Petrolatum Dressing (September 13, 2019)

Other clearances for product code KGN

  • K253521 — ECMT-100 WMD (June 18, 2026)
  • K253204 — Catalyze (June 5, 2026)
  • K254034 — Roosin Collagen Powder (June 3, 2026)
  • K261224 — MatriDerm (May 14, 2026)
  • K260532 — Derma-Gide (March 19, 2026)
  • K260218 — LacertaMatrix (February 19, 2026)
  • K253140 — CollOvine™ Wound Powder (February 10, 2026)
  • K251323 — Device 104 Particulate (January 22, 2026)
  • K253339 — Theracor (December 22, 2025)
  • K252673 — LacertaMatrix (December 22, 2025)