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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 K171388
Device Name EndoWrist Stapler 45 System and Stapler 45 Reloads
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Doreen Nakamura
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Doreen Nakamura
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GDW  
Date Received05/11/2017
Decision Date 05/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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