Da Vinci Xi Surgical System

System, Surgical, Computer Controlled Instrument

Intuitive Surgical, Inc.

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

Pre-market Notification Details

Device IDK161178
510k NumberK161178
Device Name:Da Vinci Xi Surgical System
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactBrandon Hansen
CorrespondentCindy Domecus
Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough,  CA  94010
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-26
Decision Date2017-01-19
Summary:summary

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