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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 K110946
Device Name ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
Applicant
Galil Medical , Ltd.
Yokneam Gate, 1 Tavor Bldg.
Yokneam,  IL 20692
Applicant Contact LYNNE DAVIES
Correspondent
Galil Medical , Ltd.
Yokneam Gate, 1 Tavor Bldg.
Yokneam,  IL 20692
Correspondent Contact LYNNE DAVIES
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/04/2011
Decision Date 06/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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