Haloflex Energy Generator, Models 1190A-115A and 1190A-230A

• • Terminated Z-2379-2012 FDA Class II ·initiated 3 Aug 2012

  Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.

510(k) Number

K092487 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Barrx Models HALO360 and HALO360+ Coagulation Catheters

  Class II

  FDA 510(k) K080557 Active Cleared 2 Apr 2008

• Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F

  Class II

  FDA 510(k) K060169 Active Cleared 21 Apr 2006

• Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34

  Class II

  FDA 510(k) K083711 Active Cleared 2 Feb 2009

• Halo Ablation Catheter, Model 90-9100

  Class II

  FDA 510(k) K093008 Active Cleared 8 Jan 2010

• HALO360 Energy Generator, Models 1100C-115B and 1100C-230B

  Class II

  FDA 510(k) K082202 Active Cleared 8 Oct 2008

• HALO90 Coagulation Catheter

  Class II

  FDA 510(k) K062723 Active Cleared 9 Nov 2006

See all devices from Barrx Medical, Incorporated →