FDA 510(k) Applications Submitted by Galil Medical Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K991272 |
04/13/1999 |
CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E |
GALIL MEDICAL LTD. |
| K010991 |
04/03/2001 |
SEEDNET, MODELS FP6T5, FP5T5, FP5T3 |
GALIL MEDICAL LTD. |
| K060144 |
01/19/2006 |
SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS |
GALIL MEDICAL LTD. |
| K070482 |
02/20/2007 |
ISIS |
GALIL MEDICAL LTD. |
| K980913 |
03/10/1998 |
CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 |
GALIL MEDICAL LTD. |
| K021261 |
04/19/2002 |
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 |
GALIL MEDICAL LTD. |
| K051052 |
04/25/2005 |
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) |
GALIL MEDICAL LTD. |
| K991517 |
04/30/1999 |
CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 |
GALIL MEDICAL LTD. |
| K011950 |
06/21/2001 |
SEEDNET, MODEL FP6T5, FP5T5, FP5T3 |
GALIL MEDICAL LTD. |
| K012497 |
08/03/2001 |
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 |
GALIL MEDICAL LTD. |
| K003065 |
10/02/2000 |
SEEDNET, MODEL EP6T5, EP5E5 |
GALIL MEDICAL LTD. |
| K993965 |
11/23/1999 |
CRYO-HIT |
GALIL MEDICAL LTD. |
| K060390 |
02/14/2006 |
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA |
GALIL MEDICAL LTD. |
| K052530 |
09/14/2005 |
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA |
GALIL MEDICAL LTD. |
| K042667 |
09/29/2004 |
SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) |
GALIL MEDICAL LTD. |
| K141485 |
06/05/2014 |
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE |
GALIL MEDICAL LTD. |
| K140584 |
03/07/2014 |
ICEROD CX CRYOABLATION NEEDLE |
GALIL MEDICAL LTD. |
| K110946 |
04/04/2011 |
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE |
GALIL MEDICAL LTD. |
| K121251 |
04/25/2012 |
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK |
GALIL MEDICAL LTD. |
| K162599 |
09/19/2016 |
IcePearl 2.1 CX L, IceForce 2.1 CX L |
GALIL MEDICAL LTD. |
| K031117 |
04/08/2003 |
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM |
GALIL MEDICAL LTD. |
| K181741 |
07/02/2018 |
IceSphere 1.5 CX Cryoablation Needle |
Galil Medical Ltd. |
|
|
