EndoWrist Vessel Sealer, 8 Mm Harmonic ACE Curved Shears, Da Vinci Single-Site Instruments And Accessories

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, 8 Mm Harmonic Ace Curved Shears, Da Vinci Single-site Instruments And Accessories.

Pre-market Notification Details

Device IDK170865
510k NumberK170865
Device Name:EndoWrist Vessel Sealer, 8 Mm Harmonic ACE Curved Shears, Da Vinci Single-Site Instruments And Accessories
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactCheryl Wu
CorrespondentCheryl Wu
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 Received2017-03-23
Decision Date2017-04-21
Summary:summary

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