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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K955531
Device Name ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
Applicant
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact CHERYL L SHEA
Correspondent
Arthrocare Corp.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact CHERYL L SHEA
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
KNS  
Date Received12/04/1995
Decision Date 02/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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