Da Vinci S/Si EndoWrist Instruments And Accessories, Harmonic ACE Curved Shears (5mm & 8mm)

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 Da Vinci S/si Endowrist Instruments And Accessories, Harmonic Ace Curved Shears (5mm & 8mm).

Pre-market Notification Details

Device IDK170644
510k NumberK170644
Device Name:Da Vinci S/Si EndoWrist Instruments And Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactKunal Gunjal
CorrespondentKunal Gunjal
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 Received2017-03-02
Decision Date2017-09-11
Summary:summary

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