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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K013153
Device Name AUTOTOME RX MODEL # 4515, 4516
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact LISA M QUAGLIA
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact LISA M QUAGLIA
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/20/2001
Decision Date 10/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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