INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000

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 Intuitive Surgical Da Vinci Si Surgical System: Model Is3000.

Pre-market Notification Details

Device IDK081137
510k NumberK081137
Device Name:INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale,  CA  94086 -5206
ContactKaren Uyesugi
CorrespondentKaren Uyesugi
INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale,  CA  94086 -5206
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-21
Decision Date2009-02-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886874112793 K081137 000
00886874110478 K081137 000
00886874110409 K081137 000
00886874110393 K081137 000
00886874110386 K081137 000
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00886874110362 K081137 000
00886874110348 K081137 000
00886874110195 K081137 000
00886874110188 K081137 000
00886874110683 K081137 000
00886874110690 K081137 000
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00886874110874 K081137 000
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00886874110850 K081137 000
00886874110799 K081137 000
00886874110782 K081137 000
00886874110775 K081137 000
00886874110751 K081137 000
00886874110713 K081137 000
00886874110157 K081137 000

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