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510(k) K232758

Comatryx OTC by Strukmyer Medical, LLC — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2023
Date Received
September 8, 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 Strukmyer Medical, LLC

  • K171645 — CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing (July 25, 2017)
  • K161311 — USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), (August 29, 2016)

Other clearances for product code KGN

  • 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)
  • 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)