Endotine Transbleph 3.0/3.5 Device

• • Terminated Z-2294-2016 FDA Class II ·initiated 6 May 2016

  MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).

510(k) Number

K042796 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Coapt Systems Endotine Device, Model Cfd-101-00197

  Class II

  FDA 510(k) K023922 Active Cleared 20 Dec 2002

• Vf Gel Plus

  Class II

  FDA 510(k) K071663 Active Cleared 15 Feb 2008

• Vf Liquigel

  Class II

  FDA 510(k) K083783 Active Cleared 11 Sep 2009

• Endotine Ribbon

  Class II

  FDA 510(k) K050611 Active Cleared 6 Apr 2005

• Coapt Endotine Midface-St 4.5 Device

  Class II

  FDA 510(k) K032698 Active Cleared 23 Oct 2003

• Endotine Forehead Triple Device

  Class II

  FDA 510(k) K042078 Active Cleared 27 Aug 2004

See all devices from Coapt Systems, Inc. →