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 IDK151794
510k NumberK151794
Device Name:Da Vinci Xi Surgical System
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactBrandon Hansen
CorrespondentBrandon Hansen
Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-01
Decision Date2016-01-15
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.