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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Energy Direct Current Thermal Ablation System
510(k) Number K102329
Device Name NANOKNIFE SYSTEM
Applicant
AngioDynamics, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Applicant Contact KIT CARIQUITAN
Correspondent
AngioDynamics, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Correspondent Contact KIT CARIQUITAN
Regulation Number878.4400
Classification Product Code
OAB  
Subsequent Product Code
GEI  
Date Received08/17/2010
Decision Date 10/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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