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510(k) K113866

PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX by Brennen Medical, LLC — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2012
Date Received
December 30, 2011
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 Brennen Medical, LLC

  • K111436 — PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX (October 14, 2011)
  • K081272 — PORCINE SURGICAL MESH; DERMAL MATRIX (July 31, 2008)
  • K050086 — BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING (February 17, 2006)
  • K030460 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (March 7, 2003)
  • K021835 — BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX (October 17, 2002)
  • K002078 — BETA GLUCAN GEL (MACROPRO GEL) (October 2, 2000)
  • K002077 — GLUCANPRO CREAM (October 2, 2000)
  • K000518 — MACROPRO GEL (May 1, 2000)
  • K000519 — GLUCANPRO (May 1, 2000)
  • K982825 — BRENNEN MEDICAL BETA GLUCAN GEL (November 6, 1998)

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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)