EndoWrist Suction Irrigator

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 Suction Irrigator.

Pre-market Notification Details

Device IDK162973
510k NumberK162973
Device Name:EndoWrist Suction Irrigator
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactMelissa S. Gonzalez
CorrespondentMelissa S. Gonzalez
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 Received2016-10-25
Decision Date2017-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886874114817 K162973 000

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