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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 K202006
Device Name ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System
Applicant
ArthroCare Corporation
7000 W. William Cannon Dr., Bldg. One
Austin,  TX  78749
Applicant Contact Jean Asquith
Correspondent
ArthroCare Corporation
7000 W. William Cannon Dr., Bldg. One
Austin,  TX  78749
Correspondent Contact Jean Asquith
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/21/2020
Decision Date 12/18/2020
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
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