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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 K170879
Device Name IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd. Bldg. 101
Sunnyvale,  CA  94086
Applicant Contact Kunal Gunjal
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd. Bldg. 101
Sunnyvale,  CA  94086
Correspondent Contact Kunal Gunjal
Regulation Number876.1500
Classification Product Code
NAY  
Date Received03/24/2017
Decision Date 09/21/2017
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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