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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 K180033
Device Name 8mm Monopolar Curved Scissors
Applicant
Intuitive Surgical, Inc
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Gayle Perry
Correspondent
Intuitive Surgical, Inc
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Gayle Perry
Regulation Number876.1500
Classification Product Code
NAY  
Date Received01/04/2018
Decision Date 04/06/2018
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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