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510(k) K950032

MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING by Brennen Medical, Inc. — Product Code KGN

K950032 is an FDA 510(k) premarket notification submitted by Brennen Medical, Inc. for the device "MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Brennen Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
January 4, 1995
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, Inc.

  • K113866 — PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX (March 23, 2012)
  • 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)

Other clearances for product code KGN

  • K260652 — ColActive Plus (September 9, 2026)
  • K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3c (August 27, 2026)
  • K260596 — Collagen Wound Powder (July 2, 2026)
  • K260669 — Endoform Dermal Template (June 24, 2026)
  • K253521 — ECMT-100 WMD (June 18, 2026)
  • K253204 — Catalyze (June 5, 2026)
  • K253974 — Roosin Collagen Dressing (June 3, 2026)
  • K254034 — Roosin Collagen Powder (June 3, 2026)
  • K261224 — MatriDerm (May 14, 2026)
  • K260532 — Derma-Gide (March 19, 2026)

FDA data resources