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 IDK192803
510k NumberK192803
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
ContactCrystal Ong
CorrespondentCrystal Ong
Intuitive Surgical 1266 Kifer Road Sunnyvale,  CA  94086
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-04-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886874119266 K192803 000
00886874119433 K192803 000

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