Acticoat Foam Dressing

• • Terminated Z-0016-04 FDA Unclassified (pre-2012) ·initiated 15 Apr 2003 ·on shared 510(k) K000051

  Product may not meet the established stability specification before the end of labeled expiry date.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K000051 ↗

FDA Product Code

FRO

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Acticoat 7 Dressing

  Unclassified

  FDA 510(k) K001519 Active Cleared 6 Oct 2000

• Acticoat Primary Antimicrobial Dressing

  Unclassified

  FDA 510(k) K992221 Active Cleared 7 Jun 2000

• Acticoat Composite Dressing

  Unclassified

  FDA 510(k) K002466 Active Cleared 16 Feb 2001

• Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive

  Class I

  FDA 510(k) K983833 Active Cleared 10 Dec 1998

• Modification to Acticoat Foam Dressing

  Unclassified

  FDA 510(k) K010447 Active Cleared 15 Mar 2001