Da Vinci S/Si (IS2000/IS3000) 5mm And 8mm Reusable Instruments, Da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments

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 (is2000/is3000) 5mm And 8mm Reusable Instruments, Da Vinci Xi/x (is4000/is4200) 8mm Reusable Instruments.

Pre-market Notification Details

Device IDK203632
510k NumberK203632
Device Name:Da Vinci S/Si (IS2000/IS3000) 5mm And 8mm Reusable Instruments, Da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road, Building 101 Sunnyvale,  CA  94086
ContactKunal Gunjal
CorrespondentKunal Gunjal
Intuitive Surgical, Inc. 1266 Kifer Road, Building 101 Sunnyvale,  CA  94086
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-11
Decision Date2021-02-10

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