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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 K254122
Device Name FLOW FLEXTEND Wand (72290039)
Applicant
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Applicant Contact Alexander Brankner
Correspondent
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Correspondent Contact Alexander Brankner
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/19/2025
Decision Date 03/30/2026
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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