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510(k) K212766

Maxiocel Chitosan Wound Dressing by Advamedica, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2023
Date Received
August 31, 2021
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 Advamedica, Inc.

  • K222909 — Axiostat Gauze (April 7, 2023)
  • K213198 — Ax-Surgi Surgical Hemostat (January 5, 2023)
  • K202830 — Axiostat Patch (April 15, 2021)
  • K172324 — Axiostat Chitosan Hemostatic Dressing (February 23, 2018)

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  • 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)