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510(k) K242100

SurgiAid Collagen Wound Dressing (HA) by Maxigen Biotech, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2025
Date Received
July 18, 2024
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.

  • K230529 — HealiAid Dental Collagen Wound Dressing (November 22, 2023)
  • K223126 — SurgiAid® Collagen Wound Dressing (October 11, 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)
  • 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)
  • K250329 — GeniPhys Collymer Self-Assembling Scaffold (June 25, 2025)