FDA.reportPublic FDA data

Mario Lowe

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30136656813013665681Mario Lowe1N2026-01-011266 Kifer Rd Sunnyvale CA US 94086
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
3460871649676110K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMNAY2000-07-11
3460871712454783K252069da Vinci SP Surgical System (SP1098)NAY2025-12-02
3384162054031288K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke EvacuationNAY2024-03-14
3460872073620076K201146Ion Endoluminal SystemEOQ2020-06-26
3460871317532513K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2020-04-29
3460871838498386K192367Ion Endoluminal SystemEOQ2019-11-26
3379301807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
3384161807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
3460871807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
3460871865640334K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2020-02-06
3460871682044864K191280E-100 Electrosurgical Generator, SynchroSealNAY2019-11-14
3460871849454782K191043da Vinci Handheld CameraGCJ2019-06-06
3460871318573614K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY2019-07-12
3460871412807843K183224SureForm 45, SureForm 45 ReloadsNAY2019-01-18
3460871327412692K183139Endoscope Sterilization TrayKCT2019-02-01
3460871701227604K183107Intuitive Surgical Vessel Sealer ExtendNAY2018-12-11
3460871996153611K183086da Vinci X and Xi Surgical SystemNAY2020-03-31
3460871384052137K182643IRIS 1.0 SystemLLZ2019-02-22
3460871023001908K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2019-03-14
3460871353974353K182188Ion Endoluminal System ; Flexision Biopsy NeedleEOQ2019-02-14
3460871245294265K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2018-10-24
3460871652618447K181395Universal Cannula Seal (5-12 mm)GCJ2018-07-27
3460871259658604K180964Endoscope Sterilization TrayKCT2018-09-28
1645551509308041K180351EndoWrist Mercury Bipolar GrasperNAY2018-08-07
3460871509308041K180351EndoWrist Mercury Bipolar GrasperNAY2018-08-07
1645552001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
3460872001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
3460871851755254K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2018-05-31
3460871667067088K173721SureForm 60 and SureForm 60 ReloadsNAY2018-07-05
3460871879286938K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2018-07-19
3460871230879251K173415EndoWrist 5mm Thoracic GrasperNAY2018-05-31
3460871306520926K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY2018-04-26
3460871114473670K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemNAY2018-01-31
3460871466225023K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemNAY2017-07-28
3460871951476221K171632da Vinci Xi Surgical SystemNAY2017-09-19
3460871903555570K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY2017-06-13
3460871991855356K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsNAY2017-05-31
3460871773635835K171294da Vinci X Surgical SystemNAY2017-05-26
3460871500864152K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable AccessoriesNAY2017-09-21
3460871407970436K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and AccessoriesNAY2017-04-21
3460871297692357K170713da Vinci Xi Surgical SystemNAY2017-06-13
3460871873047453K170645da Vinci Xi EndoWrist Instruments and AccessoriesNAY2017-09-11
3460871298067783K170644da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)NAY2017-09-11
3460871887523700K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesNAY2017-09-21
3460871279671856K170640Endoscope Sterilization TrayKCT2017-09-17
3460871112190839K162973EndoWrist Suction IrrigatorNAY2017-02-06
3460871148924273K162411da Vinci Xi 12 – 8 mm ReducerNAY2016-09-21
3460872021064938K161271da Vinci Xi Surgical SystemNAY2016-07-11
3460871448867061K161178da Vinci Xi Surgical SystemNAY2017-01-19
3460871192325573K153276da Vinci Xi Surgical SystemNAY2016-08-07
1645551045176031K153126da Vinci Xi Hasson ConeGCJ2015-12-09
3460871045176031K153126da Vinci Xi Hasson ConeGCJ2015-12-09
3460871704071581K152892da Vinci Xi Surgical SystemNAY2016-04-29
1645551131717527K152663Bladeless Optical ObturatorsGCJ2015-10-16
3460871131717527K152663Bladeless Optical ObturatorsGCJ2015-10-16
3460871902014994K152578da Vinci Surgical System, Model IS4000NAY2016-03-30
1645551566601086K152448da Vinci Single-Site Instrument and AccessoriesNAY2016-03-09
3460871566601086K152448da Vinci Single-Site Instrument and AccessoriesNAY2016-03-09
1645551672985548K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY2016-03-04
3460871672985548K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY2016-03-04
3460871232716681K151794da Vinci Xi Surgical SystemNAY2016-01-15
3460872001405190K151450Endoscope Sterilization TrayKCT2016-01-12
1645551022836725K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY2015-04-29
3460871022836725K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY2015-04-29
1645551941799083K150284IS4000 da Vinci EndoWrist InstrumentsNAY2015-05-15
3460871941799083K150284IS4000 da Vinci EndoWrist InstrumentsNAY2015-05-15
3460871055232770K14321712 mm & Stapler Bladeless ObturatorsNAY2014-12-03
3460871655171763K143132IS4000 8mm Harmonic ACE Curved ShearsNAY2015-04-02
3460871668534900K142937Endoscope Sterilization TrayKCT2015-02-24
3460871695985462K14268312 mm Endoscopes and AccessoriesNAY2014-12-10
1645551797047205K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
3460871797047205K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
3460871938095292K140189ENDOWRIST VESSEL SEALERNAY2014-06-05
3460871616657321K133942ENDOSCOPE STERILIZATION TRAYKCT2014-08-01
3460872066551524K1338458MM TROCAR KITGCJ2014-02-19
1645552016260083K133203SINGLE-SITE PORTGCJ2014-05-09
3460871762280882K133167MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORDGEI2014-01-07
1645551443792233K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
3460871443792233K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
1645551791132569K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
3460871791132569K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
3460871868926009K130266ENDOWRIST ONE VESSEL SEALERNAY2013-08-29
3460871505297784K123463INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALSNAY2012-12-03
1645551984046067K122532DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIESNAY2013-07-30
3460871252929030K113706ENDOWRIST STAPLER SYSTEMNAY2012-10-17
3460871601899810K1125845MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERTNAY2011-09-29
3460871397979857K112263MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORYNAY2011-10-07
1645551707849165K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
3460871707849165K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
1645551643151995K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
3460871643151995K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
1645551114366981K110451ENDOWRIST ONE SUCTION/IRRIGATORNAY2011-08-26
3460871114366981K110451ENDOWRIST ONE SUCTION/IRRIGATORNAY2011-08-26
3460871021703102K1017435MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319NAY2011-02-04
3460872014737647K101077DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100GCJ2011-02-04
3460871291271836K0932175 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)NAY2010-01-21
3460871989221702K082497INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENTNAY2009-05-07
3460871349551793K081137INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000NAY2009-02-18
3460871960203829K080155MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEMGCJ2008-03-06
3460871356004576K073112DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253NVE2008-08-01
3460871628016493K072627INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCERNAY2008-02-07
3460871741866341K072211INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYSKCT2008-02-28
3460871778391140K071405PROBE HOLDER SYSTEMLKF2007-10-09
1645551567778987K070947INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPERNAY2008-02-14
3460871567778987K070947INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPERNAY2008-02-14
3460871572440495K063220DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000NAY2006-12-01
1645551251632096K061260INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214NAY2006-05-18
3460871251632096K061260INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214NAY2006-05-18
3460871240858573K060391INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182NAY2006-04-10
1645551737257236K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000NAY2005-04-29
3460871737257236K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000NAY2005-04-29
3460871367944853K050322MICROTEK EQUIPMENT DRAPESKKX2005-05-17
1645551628733083K050005INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180NAY2005-01-25
3460871628733083K050005INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180NAY2005-01-25
3460871739415148K042855INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENTNAY2004-11-12
3460871666197795K040948INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170NAY2004-05-05
1645551680516170K021036INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000NAY2002-06-26
1645551707456219K013416INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILYGEI2002-01-10
3460871707456219K013416INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILYGEI2002-01-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NAY952025-12-02
GCJ112019-06-06
KCT72019-02-01
EOQ32020-06-26
GEI32014-01-07
LLZ12019-02-22
NVE12008-08-01
LKF12007-10-09
KKX12005-05-17