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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 K214095
Device Name da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road, Building 101
Sunnyvale,  CA  94086
Applicant Contact Kunal Gunjal
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Road, Building 101
Sunnyvale,  CA  94086
Correspondent Contact Kunal Gunjal
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GCJ  
Date Received12/28/2021
Decision Date 08/15/2022
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
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