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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K152133
Device Name 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
Applicant
Galil Medical , Ltd.
Tavor 1 Bldg.
Shaar Yokneam,  IL 20692
Applicant Contact LYNNE DAVIES
Correspondent
Galil Medical, Inc.
4364 Round Lake Rd.
Arden Hills,  MN  55112
Correspondent Contact LYNNE DAVIES
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/31/2015
Decision Date 08/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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