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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K011083
Device Name ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND
Applicant
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact BRUCE PROTHRO
Correspondent
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact BRUCE PROTHRO
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received04/10/2001
Decision Date 06/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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