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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K153675
Device Name Paragon T2 Wand with Integrated Cable
Applicant
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Applicant Contact KRYSTLE DANUZ
Correspondent
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Correspondent Contact KRYSTLE DANUZ
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/21/2015
Decision Date 01/15/2016
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
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