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510(k) K012990

COLLATEK POWDER by Biocore Medical Technologies, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2001
Date Received
September 6, 2001
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 Biocore Medical Technologies, Inc.

  • K022995 — COLLATEK HYDROGEL (December 2, 2002)
  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (October 25, 2001)

Other clearances for product code KGN

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  • K253140 — CollOvine™ Wound Powder (February 10, 2026)
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  • 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)