# Galil Medical, Ltd.

- Location (FDA's records): Washington, DC
- FDA decisions: 31 (1998–2020): 31 510(k) clearances
- Names in FDA's records: Galil Medical , Ltd. (23); Galil Medical, Inc. (8)
- Product codes: GEH (29), NEY (1), GEI (1)
- 510(k) review time since 2016: median 28 days, against 72 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 51 (48 its own); citations of its devices by later devices: 67 (48 its own)
- Recalls linked to its devices: 53 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Covidien: 2 (https://510kreport.com/company/covidien)
- Endocare, Inc.: 1 (https://510kreport.com/company/endocare)

## Firms that cite its devices most
- Boston Scientific Corp: 6 (https://510kreport.com/company/boston-scientific)
- Healthtronics: 3 (https://510kreport.com/company/healthtronics)
- AtriCure, Inc.: 2 (https://510kreport.com/company/atricure)
- IceCure Medical, Ltd.: 2 (https://510kreport.com/company/icecure-medical)
- Amertek Medical, Inc.: 1 (https://510kreport.com/company/amertek-medical)
- UC-CARE, Ltd.: 1 (https://510kreport.com/company/uc-care)
- Medinux (Tianjin) Technologies Co., Ltd.: 1 (https://510kreport.com/company/medinux-tianjin-technologies)
- Brymill Cryogenic Systems: 1 (https://510kreport.com/company/brymill-cryogenic-systems)

## Its most-cited devices
- K113860: Visual-Ice Cryoablation System (2012), cited by 5
- K991517: Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 (1999), cited by 4
- K152133: IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System (2015), cited by 4
- K121251: Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack (2012), cited by 4
- K980913: Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 (1998), cited by 4
- K140584: Icerod CX Cryoablation Needle (2014), cited by 4

## Recent decisions
- 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 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle (Nov 2, 2020)
- K200061: HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) (Jul 9, 2020)
- K181741: IceSphere 1.5 CX Cryoablation Needle (Jul 30, 2018)
- K181153: ICEfx Cryoablation System (May 15, 2018)
- K173037: Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel (Nov 21, 2017)
- K162599: IcePearl 2.1 CX L, IceForce 2.1 CX L (Oct 11, 2016)
- K152133: IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System (Aug 28, 2015)
- K143564: Visual-ICE Cryoablation System, Software Revision 1.3.1 (Mar 5, 2015)

Source page: https://510kreport.com/company/galil-medical