INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182

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 Endowrist Stabilizer, Model 420182.

Pre-market Notification Details

Device IDK060391
510k NumberK060391
Device Name:INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale,  CA  94086 -5206
ContactMichael J Hyramategui
CorrespondentMichael J Hyramategui
INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale,  CA  94086 -5206
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-15
Decision Date2006-04-10
Summary:summary

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