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510(k) K223126

SurgiAid® Collagen Wound Dressing by Maxigen Biotech, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2023
Date Received
October 3, 2022
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 Maxigen Biotech, Inc.

  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
  • K230529 — HealiAid Dental Collagen Wound Dressing (November 22, 2023)
  • K100927 — SURGIAID (February 2, 2011)

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)