DA VINCI SINGLE-SITE 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 Single-site Instruments And Accessories.

Pre-market Notification Details

Device IDK122532
510k NumberK122532
Device Name:DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale,  CA  94086 -5206
ContactMelissa S Gonzalez
CorrespondentMelissa S Gonzalez
INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale,  CA  94086 -5206
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-20
Decision Date2013-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886874112083 K122532 000
10886874112066 K122532 000
00886874111956 K122532 000
00886874111888 K122532 000

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