Company · US
Galil Medical , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2020. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 2, 2020 | K203032 | IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2 Galil Medical, Inc. | GEH |
| Jul 9, 2020 | K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-P Galil Medical, Inc. | NEY |
| Jul 30, 2018 | K181741 | IceSphere 1.5 CX Cryoablation Needle Galil Medical , Ltd., IL | GEH |
| May 15, 2018 | K181153 | ICEfx Cryoablation System Galil Medical, Inc. | GEH |
| Nov 21, 2017 | K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel Galil Medical, Inc. | GEH |
| Oct 11, 2016 | K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX L Galil Medical , Ltd., IL | GEH |
| Aug 28, 2015 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoab Galil Medical , Ltd., IL | GEH |
| Mar 5, 2015 | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 Galil Medical, Inc. | GEH |
| Jul 2, 2014 | K141485 | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE Galil Medical , Ltd. | GEH |
| Mar 31, 2014 | K140584 | ICEROD CX CRYOABLATION NEEDLE Galil Medical , Ltd. | GEH |
| Feb 6, 2013 | K123865 | VISUAL-ICE CRYOABLATION SYSTEM Galil Medical, Inc. | GEH |
| Aug 28, 2012 | K121251 | ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK Galil Medical , Ltd. | GEH |
| Mar 12, 2012 | K113860 | VISUAL-ICE CRYOABLATION SYSTEM Galil Medical, Inc. | GEH |
| Oct 7, 2011 | K111859 | ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK Galil Medical, Inc. | GEH |
| Jun 21, 2011 | K110946 | ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE Galil Medical , Ltd., IL | GEH |
| Mar 20, 2007 | K070482 | ISIS Galil Medical , Ltd. | GEH |
| Apr 27, 2006 | K060390 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA Galil Medical , Ltd. | GEH |
| Feb 13, 2006 | K060144 | SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS Galil Medical , Ltd. | GEH |
| Nov 18, 2005 | K052530 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA Galil Medical , Ltd. | GEH |
| May 6, 2005 | K051052 | SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) Galil Medical , Ltd. | GEH |
| Oct 14, 2004 | K042667 | SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) Galil Medical , Ltd. | GEH |
| May 23, 2003 | K031117 | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM Galil Medical , Ltd., IL | GEH |
| Jul 3, 2002 | K021261 | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 Galil Medical , Ltd. | GEH |
| Jan 29, 2002 | K011950 | SEEDNET, MODEL FP6T5, FP5T5, FP5T3 Galil Medical , Ltd. | GEH |
| Oct 30, 2001 | K012497 | CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 Galil Medical , Ltd. | GEH |
| May 3, 2001 | K010991 | SEEDNET, MODELS FP6T5, FP5T5, FP5T3 Galil Medical , Ltd. | GEH |
| Oct 31, 2000 | K003065 | SEEDNET, MODEL EP6T5, EP5E5 Galil Medical , Ltd. | GEH |
| Feb 18, 2000 | K993965 | CRYO-HIT Galil Medical , Ltd. | GEH |
| Jul 27, 1999 | K991517 | CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 Galil Medical , Ltd. | GEH |
| Jul 12, 1999 | K991272 | CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E Galil Medical , Ltd. | GEH |
| Jul 1, 1998 | K980913 | CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 Galil Medical , Ltd. | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2019 | Galil Medical, Inc. Visual-ICE Cryoablation System, FPRCH6000.
The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer Terminated |
GEH | K113860 K123865 +1 |
| Aug 23, 2012 | Galil Medical, Inc. Visual-ICE Cryoablation System, Model FPRCH 6000
Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedure Terminated |
GEH | K113860 |
| May 16, 2012 | Galil Medical, Inc. Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO.
Product Usage:
Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medic Terminated |
GEH | K060144 |
| Feb 3, 2011 | Galil Medical, Inc. SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved in the US: CryoHit MRI Cryoblation System, model FPRCH2048. The system is a software controlled cryoblatio Terminated |
GEH | K021261 K051052 |
| Feb 3, 2011 | Galil Medical, Inc. Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. The system is a software controlled cryoblation syst Terminated |
GEH | K060390 |
| Dec 29, 2010 | Galil Medical Urethral Warmer System Model number FPRCH3001
The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures whil Terminated |
GEH | K010991 |
| Sep 3, 2008 | Galil Medical Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue. Terminated |
GEH | K012497 |