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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 K183346
Device Name FLOW 90 Wand
Applicant
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Applicant Contact Shruthi Bhat
Correspondent
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Correspondent Contact Shruthi Bhat
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/03/2018
Decision Date 01/24/2019
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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