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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 K220023
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 Received01/05/2022
Decision Date 01/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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