Da Vinci Xi Surgical System, Da Vinci X Surgical System

System, Surgical, Computer Controlled Instrument

Intuitive Surgical

The following data is part of a premarket notification filed by Intuitive Surgical with the FDA for Da Vinci Xi Surgical System, Da Vinci X Surgical System.

Pre-market Notification Details

Device IDK191529
510k NumberK191529
Device Name:Da Vinci Xi Surgical System, Da Vinci X Surgical System
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical 1266 Kifer Road Sunnyvale,  CA  94086
ContactVishal Kanani
CorrespondentVishal Kanani
Intuitive Surgical 1266 Kifer Road Sunnyvale,  CA  94086
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-10
Decision Date2020-02-06

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