MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY

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 Monopolar Curved Scissors Tip Cover Accessory.

Pre-market Notification Details

Device IDK112263
510k NumberK112263
Device Name:MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale,  CA  94086 -5206
ContactBrandon Hansen
CorrespondentBrandon Hansen
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 Received2011-08-08
Decision Date2011-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886874111045 K112263 000

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