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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 K171426
Device Name da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact Brittany Cunningham
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact Brittany Cunningham
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GCJ  
Date Received05/15/2017
Decision Date 06/13/2017
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
Predetermined Change
Control Plan Authorized		 No
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