INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000

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 Intuitive Surgical Da Vinci S Surgical System With Da Vinci Connect & Da Vinci Onsite, Model Is2000.

Pre-market Notification Details

Device IDK101581
510k NumberK101581
Device Name:INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale,  CA  94086 -5206
ContactBrandon Hansen
CorrespondentBrandon Hansen
INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale,  CA  94086 -5206
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-07
Decision Date2011-04-08
Summary:summary

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