FDA.reportPublic FDA data

Mario Lowe

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30381874663038187466Mario Lowe1N2026-01-011266 Kifer Rd Sunnyvale CA US 94086
30381888393038188839Mario Lowe1N2026-01-011266 Kifer Rd Sunnyvale CA US 94086
30106061433010606143Mario Lowe1N2020-04-251266 Kifer Rd Sunnyvale CA US 94086

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1645551649676110K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMNAY2000-07-11
3384161807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
3379301807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
1645551509308041K180351EndoWrist Mercury Bipolar GrasperNAY2018-08-07
1645552001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
1645551045176031K153126da Vinci Xi Hasson ConeGCJ2015-12-09
1645551131717527K152663Bladeless Optical ObturatorsGCJ2015-10-16
1645551566601086K152448da Vinci Single-Site Instrument and AccessoriesNAY2016-03-09
1645551672985548K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY2016-03-04
1645551022836725K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY2015-04-29
1645551941799083K150284IS4000 da Vinci EndoWrist InstrumentsNAY2015-05-15
1645551797047205K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
1645552016260083K133203SINGLE-SITE PORTGCJ2014-05-09
1645551443792233K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
1645551791132569K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
1645551984046067K122532DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIESNAY2013-07-30
1645551707849165K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
1645551643151995K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
1645551114366981K110451ENDOWRIST ONE SUCTION/IRRIGATORNAY2011-08-26
1645551567778987K070947INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPERNAY2008-02-14
1645551251632096K061260INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214NAY2006-05-18
1645551737257236K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000NAY2005-04-29
1645551628733083K050005INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180NAY2005-01-25
1645551680516170K021036INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000NAY2002-06-26
1645551707456219K013416INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILYGEI2002-01-10
1645552052524529K012833INTUITIVE SURGICAL BIPOLAR FORCEPSNAY2001-11-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NAY222019-07-26
GCJ32015-12-09
GEI12002-01-10