GALIL MEDICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004462490	3004462490	GALIL MEDICAL INC.	1	Y	2020-04-25	4364 Round Lake Road Arden Hills MN US 55112

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00859019006318	Visual-ICE MRI Cryoablation Console - MRI Cryoablation System Console	651-287-5000	galil.cst@btgplc.com

btgplc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
233879	1888807604	K181153	ICEfx Cryoablation System	GEH	2018-05-15
233879	1950993291	K173037	Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel	GEH	2017-11-21
233879	1977621081	K113860	VISUAL-ICE CRYOABLATION SYSTEM	GEH	2012-03-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEH	3	2018-05-15

PMN#

HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
2020-07-09
Galil Medical Inc.
ICEfx Cryoablation System
2018-05-15
Galil Medical Inc.
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel
2017-11-21
Galil Medical Inc.
Visual-ICE Cryoablation System, Software Revision 1.3.1
2015-03-05
GALIL MEDICAL INC.
VISUAL-ICE CRYOABLATION SYSTEM
2013-02-06
GALIL MEDICAL INC.
VISUAL-ICE CRYOABLATION SYSTEM
2012-03-12
GALIL MEDICAL INC.
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
2011-10-07
GALIL MEDICAL INC.

GUDID#

HEATfx 2.1 20cm Needle - Microwave ablation needle
GALIL MEDICAL INC.
2020-10-30
HEATfx 2.1 15cm Needle - Microwave ablation needle
GALIL MEDICAL INC.
2020-10-30
HEATfx Microwave Ablation System - Microwave ablation system console
GALIL MEDICAL INC.
2020-09-24
HEATfx Microwave Ablation System - Microwave ablation system console
GALIL MEDICAL INC.
2020-08-14
HEATfx 2.1 20cm Needle - Microwave ablation needle
GALIL MEDICAL INC.
2020-08-14
HEATfx 2.1 15cm Needle - Microwave ablation needle
GALIL MEDICAL INC.
2020-08-14
Visual-ICE MRI Cryoablation Console - MRI Cryoablation System Console
GALIL MEDICAL INC.
2018-03-07
Visual-ICE MRI Junction Box Assembly - MRI Junction Box Assembly
GALIL MEDICAL INC.
2018-03-07
Visual-ICE MRI Mobile Connection Panel - MRI Mobile Connection Panel
GALIL MEDICAL INC.
2018-03-07
Visual-ICE® Cryoablation System - Cryoablation System
GALIL MEDICAL INC.
2017-02-15
EZ CONNECT2™ Dual Cylinder Adapter, psi - Visual-ICE Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
EZ CONNECT2™ Dual Cylinder Adapter, bar - Visual-ICE Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Argon Supply Line (8 m), bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Helium Supply Line (8 m), bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Argon Supply Line (3 m), bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Helium Supply Line (3 m), bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Argon Supply Line (8 m), psi - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Helium Supply Line (8 m), psi - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Gas Supply Line (8 m) - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Gas Supply Line (3 m) - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Argon Auxiliary Line (3 m) - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
AR Supply Hose, 4.5m, bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
AR Supply Hose, 4.5m, psi - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
HE Supply Hose, 4.5m, bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
HE Supply Hose, 4.5m, psi - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Supply Hose 4.5m w/o gauge - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
ICEfx Cryoablation System - Cryoablation System
GALIL MEDICAL INC.
2018-08-01
HEATfx Cart - Microwave Ablation System Accessory
GALIL MEDICAL INC.
2020-08-14
Argon Supply Line (5 m), psi - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Argon Supply Line (5 m), bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Helium Supply Line (5 m), psi - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Helium Supply Line (5 m), bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Gas Supply Line (5 m) - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Gas Supply Line (8 m) - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Argon Auxiliary Line (1.22 m) - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Argon Supply Line (8 m), psi - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Argon Supply Line (8 m), bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Helium Supply Line (8 m), psi - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
Helium Supply Line (8 m), bar - Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15
EZ CONNECT2™ Dual Cylinder Adapter, bar - Visual-ICE Cryoablation System Accessory
GALIL MEDICAL INC.
2016-08-15

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