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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Surgical, Computer Controlled Instrument
510(k) Number K113706
Device Name ENDOWRIST STAPLER SYSTEM
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Applicant Contact MEGHNA SRIDHARAN
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Correspondent Contact MEGHNA SRIDHARAN
Regulation Number876.1500
Classification Product Code
NAY  
Date Received12/16/2011
Decision Date 10/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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