FDA.reportPublic FDA data

Intuitive Surgical G.K.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30132836203013283620Intuitive Surgical G.K.1N2027-01-013-9-2 Tatsumi Koto-ku Tokyo JP 135-0053

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2388571649676110K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMNAY2000-07-11
2388571804001221K220299Ion Endoluminal System (IF1000)EOQ2022-06-16
2388571585445372K2200238mm Monopolar Curved ScissorsNAY2022-01-31
2388571354427278K214095da Vinci X/Xi (IS4200/IS4000) 8mm Reusable InstrumentsNAY2022-08-15
2388572073620076K201146Ion Endoluminal SystemEOQ2020-06-26
2388571838498386K192367Ion Endoluminal SystemEOQ2019-11-26
2388571807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
2388571682044864K191280E-100 Electrosurgical Generator, SynchroSealNAY2019-11-14
2388571849454782K191043da Vinci Handheld CameraGCJ2019-06-06
2388571318573614K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY2019-07-12
2388571412807843K183224SureForm 45, SureForm 45 ReloadsNAY2019-01-18
2388571327412692K183139Endoscope Sterilization TrayKCT2019-02-01
2388571384052137K182643IRIS 1.0 SystemLLZ2019-02-22
2388571023001908K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2019-03-14
2388571353974353K182188Ion Endoluminal System ; Flexision Biopsy NeedleEOQ2019-02-14
2388571652618447K181395Universal Cannula Seal (5-12 mm)GCJ2018-07-27
2388571509308041K180351EndoWrist Mercury Bipolar GrasperNAY2018-08-07
2388572001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
2388571667067088K173721SureForm 60 and SureForm 60 ReloadsNAY2018-07-05
2388571230879251K173415EndoWrist 5mm Thoracic GrasperNAY2018-05-31
2388571306520926K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY2018-04-26
2388571903555570K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY2017-06-13
2388571991855356K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsNAY2017-05-31
2388571773635835K171294da Vinci X Surgical SystemNAY2017-05-26
2388571112190839K162973EndoWrist Suction IrrigatorNAY2017-02-06
2388571148924273K162411da Vinci Xi 12 – 8 mm ReducerNAY2016-09-21
2388571045176031K153126da Vinci Xi Hasson ConeGCJ2015-12-09
2388571704071581K152892da Vinci Xi Surgical SystemNAY2016-04-29
2388571131717527K152663Bladeless Optical ObturatorsGCJ2015-10-16
2388571566601086K152448da Vinci Single-Site Instrument and AccessoriesNAY2016-03-09
2388571672985548K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY2016-03-04
2388571232716681K151794da Vinci Xi Surgical SystemNAY2016-01-15
2388572001405190K151450Endoscope Sterilization TrayKCT2016-01-12
2388571022836725K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY2015-04-29
2388571941799083K150284IS4000 da Vinci EndoWrist InstrumentsNAY2015-05-15
2388571055232770K14321712 mm & Stapler Bladeless ObturatorsNAY2014-12-03
2388571655171763K143132IS4000 8mm Harmonic ACE Curved ShearsNAY2015-04-02
2388571668534900K142937Endoscope Sterilization TrayKCT2015-02-24
2388571695985462K14268312 mm Endoscopes and AccessoriesNAY2014-12-10
2388571412240705K141077DA VINCI FIREFLY IMAGING SYSTEMNAY2014-08-12
2388571156174826K141075SINGLE-SITE WRISTED NEEDLE DRIVERNAY2014-09-26
2388571797047205K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
2388571938095292K140189ENDOWRIST VESSEL SEALERNAY2014-06-05
2388571616657321K133942ENDOSCOPE STERILIZATION TRAYKCT2014-08-01
2388572066551524K1338458MM TROCAR KITGCJ2014-02-19
2388572016260083K133203SINGLE-SITE PORTGCJ2014-05-09
2388571762280882K133167MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORDGEI2014-01-07
2388571443792233K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
2388571791132569K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
2388571868926009K130266ENDOWRIST ONE VESSEL SEALERNAY2013-08-29
2388571984046067K122532DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIESNAY2013-07-30
2388571252929030K113706ENDOWRIST STAPLER SYSTEMNAY2012-10-17
2388571601899810K1125845MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERTNAY2011-09-29
2388571397979857K112263MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORYNAY2011-10-07
2388571707849165K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
2388571643151995K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
2388571114366981K110451ENDOWRIST ONE SUCTION/IRRIGATORNAY2011-08-26
2388571021703102K1017435MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319NAY2011-02-04
2388572014737647K101077DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100GCJ2011-02-04
2388571291271836K0932175 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)NAY2010-01-21
2388571349551793K081137INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000NAY2009-02-18
2388571776029359K080291INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZERNAY2008-03-19
2388571960203829K080155MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEMGCJ2008-03-06
2388571356004576K073112DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253NVE2008-08-01
2388571628016493K072627INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCERNAY2008-02-07
2388571741866341K072211INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYSKCT2008-02-28
2388571778391140K071405PROBE HOLDER SYSTEMLKF2007-10-09
2388571567778987K070947INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPERNAY2008-02-14
2388571572440495K063220DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000NAY2006-12-01
2388571251632096K061260INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214NAY2006-05-18
2388571240858573K060391INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182NAY2006-04-10
2388571737257236K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000NAY2005-04-29
2388571367944853K050322MICROTEK EQUIPMENT DRAPESKKX2005-05-17
2388571628733083K050005INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180NAY2005-01-25
2388571739415148K042855INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENTNAY2004-11-12
2388571666197795K040948INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170NAY2004-05-05
2388571680516170K021036INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000NAY2002-06-26
2388571707456219K013416INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILYGEI2002-01-10
2388572052524529K012833INTUITIVE SURGICAL BIPOLAR FORCEPSNAY2001-11-16
2388571176113119K010007ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAPGCJ2001-02-22
2388571988889859K001666MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEMGCJ2000-08-24
2388571057668697
2388571224017324
2388571480841795
2388571749732422
2388571832367824
2388571895476717

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NAY562022-08-15
GCJ102019-06-06
KCT52019-02-01
EOQ42022-06-16
GEI22014-01-07
LLZ12019-02-22
NVE12008-08-01
LKF12007-10-09
KKX12005-05-17