E-Z Derm Biosynthetic Wound Dressing

• • Terminated Z-1243-2019 FDA Class II ·initiated 26 Mar 2019

  Intermittent heat seal failures on the outer pouch of some EZ Derm products.

510(k) Number

K935189 ↗

FDA Product Code

KGN

FDA applicant

Brennen Medical, Inc.

Device Class

U

Advisory Committee

Unknown

FDA Decision

SN

• Brennen Medical Beta Glucan Cream, Macropro

  Unclassified

  FDA 510(k) K980962 Active Cleared 29 Jul 1998

• Brennen Medical Beta Glucan Gel

  Unclassified

  FDA 510(k) K982825 Active Cleared 6 Nov 1998

• Porcine Dermal Xenografts Porcine Dermal Matrix

  Unclassified

  FDA 510(k) K113866 Active Cleared 23 Mar 2012

• Novagel Silicone Gel Sheeting

  Class I

  FDA 510(k) K941125 Active Cleared 31 May 1994

• Brennen Medical Silver Glucan Wound Dressing

  Unclassified

  FDA 510(k) K050086 Active Cleared 17 Feb 2006

• Brennen Medical Glucan Ii Wound Dressing

  Unclassified

  FDA 510(k) K964241 Active Cleared 12 Dec 1996

See all devices from Brennen Medical, LLC →