E-100 Electrosurgical Generator, SynchroSeal

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 E-100 Electrosurgical Generator, Synchroseal.

Pre-market Notification Details

Device IDK191280
501k NumberK191280
Device Name:E-100 Electrosurgical Generator, SynchroSeal
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactMelissa Gonzalez
CorrespondentMelissa Gonzalez
Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-13
Decision Date2019-11-14

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