Modification to Brennen Biosynthetic Surgical Mesh Matrix

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K030460 ↗

FDA Product Code

PAG

FDA applicant

Brennen Medical, Inc.

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 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 →