Intuitive Surgical EndoWrist Vessel Sealer Extend

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 Vessel Sealer Extend.

Pre-market Notification Details

Device IDK173337
510k NumberK173337
Device Name:Intuitive Surgical EndoWrist Vessel Sealer Extend
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactCrystal Ong
CorrespondentCrystal Ong
Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-23
Decision Date2018-04-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886874115661 K173337 000

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