Da Vinci SP Surgical System, EndoWrist SP 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 Da Vinci Sp Surgical System, Endowrist Sp Instruments, And Accessories.

Pre-market Notification Details

Device IDK173906
510k NumberK173906
Device Name:Da Vinci SP Surgical System, EndoWrist SP Instruments, And Accessories
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
ContactElaine Lee
CorrespondentElaine Lee
Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale,  CA  94086
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-22
Decision Date2018-05-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886874115671 K173906 000
00886874113493 K173906 000
10886874113506 K173906 000
00886874113516 K173906 000
00886874114285 K173906 000
00886874114292 K173906 000
00886874114308 K173906 000
00886874114315 K173906 000
00886874114322 K173906 000
00886874114339 K173906 000
10886874114350 K173906 000
10886874114374 K173906 000
00886874114384 K173906 000
00886874114735 K173906 000
00886874114742 K173906 000
00886874115190 K173906 000
00886874115213 K173906 000
00886874113486 K173906 000

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