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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 K152421
Device Name IS4000 Stapler 30 Instrument and Stapler 30 Reloads
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Applicant Contact MANISH PATEL
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
SUNNYVALE,  CA  94086
Correspondent Contact MANISH PATEL
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GDW  
Date Received08/26/2015
Decision Date 03/04/2016
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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