Visual-Ice Cryoablation System

• • Terminated Z-0404-2020 FDA Class II ·initiated 25 Oct 2019

  Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.

• • Terminated Z-2261-2012 FDA Class II ·initiated 20 Jul 2012

  Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.

510(k) Number

K113860 ↗

FDA Product Code

GEH

FDA applicant

Galil Medical, Inc.

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cryo-Hit Ii, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5

  Class II

  FDA 510(k) K991517 Active Cleared 27 Jul 1999

• Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024 (Seednetgold)

  Class II

  FDA 510(k) K042667 Active Cleared 14 Oct 2004

• IceEdge 2.4 Cryoablation Needle

  Class II

  FDA 510(k) K111859 Active Cleared 7 Oct 2011

• Visual-Ice Cryoablation System

  Class II

  FDA 510(k) K123865 Active Cleared 6 Feb 2013

• Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3

  Class II

  FDA 510(k) K021261 Active Cleared 3 Jul 2002

• ICEfx Cryoablation System

  Class II

  FDA 510(k) K181153 Active Cleared 15 May 2018

See all devices from Galil Medical Ltd →