Galil Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
31
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0404-2020Class IIVisual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intenOctober 25, 2019
Z-2261-2012Class IIVisual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE CrJuly 20, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K203032IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90November 2, 2020
K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2July 9, 2020
K181741IceSphere 1.5 CX Cryoablation NeedleJuly 30, 2018
K181153ICEfx Cryoablation SystemMay 15, 2018
K173037Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile ConnNovember 21, 2017
K162599IcePearl 2.1 CX L, IceForce 2.1 CX LOctober 11, 2016
K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IcAugust 28, 2015
K143564Visual-ICE Cryoablation System, Software Revision 1.3.1March 5, 2015
K141485ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLEJuly 2, 2014
K140584ICEROD CX CRYOABLATION NEEDLEMarch 31, 2014
K123865VISUAL-ICE CRYOABLATION SYSTEMFebruary 6, 2013
K121251ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACKAugust 28, 2012
K113860VISUAL-ICE CRYOABLATION SYSTEMMarch 12, 2012
K111859ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACKOctober 7, 2011
K110946ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLEJune 21, 2011
K070482ISISMarch 20, 2007
K060390SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERAApril 27, 2006
K060144SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMSFebruary 13, 2006
K052530SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERANovember 18, 2005
K051052SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)May 6, 2005