FDA 510(k) Applications Submitted by Galil Medical Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200061 |
01/13/2020 |
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) |
Galil Medical Inc. |
| K111859 |
06/30/2011 |
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK |
GALIL MEDICAL INC. |
| K203032 |
10/05/2020 |
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 2.1 CX L 90░ Needle, IceFORCE 2.1 CX Needle |
Galil Medical Inc. |
| K143564 |
12/16/2014 |
Visual-ICE Cryoablation System, Software Revision 1.3.1 |
GALIL MEDICAL INC. |
| K123865 |
12/17/2012 |
VISUAL-ICE CRYOABLATION SYSTEM |
GALIL MEDICAL INC. |
| K113860 |
12/30/2011 |
VISUAL-ICE CRYOABLATION SYSTEM |
GALIL MEDICAL INC. |
| K173037 |
09/28/2017 |
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel |
Galil Medical Inc. |
| K181153 |
05/01/2018 |
ICEfx Cryoablation System |
Galil Medical Inc. |
|
|
