HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)

System, Ablation, Microwave And Accessories

Galil Medical Inc.

The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Heatfx Microwave Ablation System, Heatfx Microwave Ablation System Cart, Heatfx 2.1 Needle, Heatfx 2.1 S Needle, Multi-point Thermal Sensor (mts).

Pre-market Notification Details

Device IDK200061
510k NumberK200061
Device Name:HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
ClassificationSystem, Ablation, Microwave And Accessories
Applicant Galil Medical Inc. 4364 Round Lake Road Arden Hills,  MN  55112
ContactAmy Mckinney
CorrespondentAmy Mckinney
Galil Medical Inc. 4364 Round Lake Road Arden Hills,  MN  55112
Product CodeNEY  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-13
Decision Date2020-07-09

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