Visecera Retainer

• • Terminated Z-1156-06 FDA Unclassified (pre-2012) ·initiated 17 Aug 2004 ·via K802806, on the same 510(k)

  Devices for which sterility may be compromised as evidenced by a loss of package integrity.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K802806 ↗

FDA Product Code

GCZ

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Goott Multipurpose Flexible Retractor (Sterile)

  Class I

  FDA 510(k) K893869 Active Cleared 3 Aug 1989

• Adams Breast Implant Protector

  Class I

  FDA 510(k) K893870 Active Cleared 14 Jul 1989

• Goott Balfour Blade

  Class I

  FDA 510(k) K893871 Active Cleared 3 Aug 1989

• Mcnealy-Glassman Viscera Retainer #3202/3204/3206

  Class I

  FDA 510(k) K870809 Active Cleared 19 Mar 1987

• Gravespec

  Class II

  FDA 510(k) K935636 Active Cleared 25 Mar 1994