ENDOWRIST VESSEL SEALER

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 Endowrist Vessel Sealer.

Pre-market Notification Details

Device IDK140189
510k NumberK140189
Device Name:ENDOWRIST VESSEL SEALER
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale,  CA  94086
ContactNadine Nasr
CorrespondentNadine Nasr
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 Received2014-01-24
Decision Date2014-06-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886874112745 K140189 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.