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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 K170508
Device Name EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact Cheryl Wu
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact Cheryl Wu
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GDW  
Date Received02/21/2017
Decision Date 03/10/2017
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
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