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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 K232610
Device Name da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Melissa S Gonzalez
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Melissa S Gonzalez
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
HIF  
Date Received08/28/2023
Decision Date 03/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT05682742
Reviewed by Third Party No
Combination Product No
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