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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 K190999
Device Name SureForm 45 Curved Tip, SureForm 45 Gray Reload
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Nadine Nasr
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Nadine Nasr
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GDW  
Date Received04/16/2019
Decision Date 07/12/2019
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
Recalls CDRH Recalls
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