Da Vinci X/Xi 8mm Endoscope Plus, 0, Da Vinci X/Xi 8mm Endoscope Plus, 30

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 X/xi 8mm Endoscope Plus, 0, Da Vinci X/xi 8mm Endoscope Plus, 30.

Pre-market Notification Details

Device IDK191736
510k NumberK191736
Device Name:Da Vinci X/Xi 8mm Endoscope Plus, 0, Da Vinci X/Xi 8mm Endoscope Plus, 30
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-28
Decision Date2019-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886874116562 K191736 000
00886874116555 K191736 000

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