ICEfx Cryoablation System

Unit, Cryosurgical, Accessories

Galil Medical Inc.

The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Icefx Cryoablation System.

Pre-market Notification Details

Device IDK181153
510k NumberK181153
Device Name:ICEfx Cryoablation System
ClassificationUnit, Cryosurgical, Accessories
Applicant Galil Medical Inc. 4364 Round Lake Road Arden Hills,  MN  55112
ContactRachel Owens
CorrespondentRachel Owens
Galil Medical Inc. 4364 Round Lake Road Arden Hills,  MN  55112
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-01
Decision Date2018-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859019006387 K181153 000
00859019006370 K181153 000

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