Da Vinci Surgical System, Model IS4000

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 Surgical System, Model Is4000.

Pre-market Notification Details

Device IDK152578
510k NumberK152578
Device Name:Da Vinci Surgical System, Model IS4000
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 Received2015-09-10
Decision Date2016-03-30
Summary:summary

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