Da Vinci SP Surgical System (SP1098)

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 Sp Surgical System (sp1098).

Pre-market Notification Details

Device IDK211595
510k NumberK211595
Device Name:Da Vinci SP Surgical System (SP1098)
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactConnor Mccarty
CorrespondentConnor Mccarty
Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-24
Decision Date2021-06-23

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.