FDA Registration Active 🇯🇵 Japan

Intuitive Surgical G.K.

Reg #: 3013283620 · FEI: 3013283620 · Expires 2026
Products
16
Proprietary Names
419
Establishment Types
2
Classifications
16

Registration Details

Registration Name
Intuitive Surgical G.K.
Registration Number
3013283620
FEI Number
3013283620
Status
Active
Expiry Year
2026
Initial Importer
No
Address
3-9-2 Tatsumi, Koto-ku
City
Tokyo
Country
JP

Regulatory Submissions

510(k) Number
K010007

Owner / Operator

Firm Name
Intuitive Surgical, Inc.
Operator Number
9028901
Address
1266 Kifer Road, --
City
Sunnyvale
State
CA
Postal Code
94086
Country
US
Correspondent
Ted Claiborne

Products

Device Name Product Code
Laparoscope, General & Plastic Surgery GCJ
System, Surgical, Computer Controlled Instrument NAY
Staple, Implantable GDW
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Instrument, Ultrasonic Surgical LFL
Drape, Surgical, Antimicrobial KKX
Electrosurgical, Cutting & Coagulation & Accessories GEI
System, X-Ray, Angiographic IZI
System, Image Processing, Radiological LLZ
Washer, Cleaner, Automated, Endoscope NVE
Bronchoscope (Flexible Or Rigid) EOQ
Cannula, Manipulator/Injector, Uterine LKF
Accessories, Cleaning Brushes, For Endoscope MNL
Unit, Cryosurgical, Accessories GEH
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Drape, Surgical, Ent ERY

Proprietary Names

Teleflex Obturators SureForm 45, SureForm 45 Reloads Endoscope Sterilization Tray Intuitive Surgical da Vinci Surgical System EndoWrist Stabilizer da Vinci S Surgical System Harmonic ACE EndoWrist One Suction/Irrigator, 8mm, da Vinci Si EndoWrist One Suction/Irrigator ICB, Instrument Control Box EndoWrist One Vessel Sealer , 8mm, da Vinci Si Endopass Delivery Instrument EndoPass Endoscopic Delivery Instruments EndoWrist Vessel Sealer da Vinci Xi 12-8 mm Reducer Fluorescence Imaging Kit 8mm 0 degree endoscope 8mm 30 degree endoscope E-100 SynchroSeal da Vinci Xi 8 mm Hasson Cone da Vinci Xi 12 mm and Stapler Hasson Cone SureForm 60 Reloads SureForm 60 Instrument/Accessory Steriliz Tray Single Instrument Tray, da Vinci, da Vinci S, Si Instrument Tray, da Vinci, da Vinci S, Si Procedure Tray, da Vinci, da Vinci S, Si IS4000 ACCESSORY STARTER KIT IS4200 ACCESSORY STARTER KIT iESU SureForm 45 Curved Tip, SureForm 45 Gray Reload 5 mm Flared Cannula, da Vinci S, Si Single-Site 10 mm Accessory Cannula, da Vinci Si Single-Site Port for 8.5 mm Endoscope, da Vinci Si Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si Single-Site Bipolar Maryland, 5mm, da Vinci Si da Vinci Single-Site Port da Vinci Single-Site Instruments and Accessories Single-Site 10 mm Blunt Obturator, da Vinci Si Single-Site Starter Kit US, Cholecystectomy, 20 Cases Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si Single-Site Maryland Dissector , 5mm, da Vinci Si Single-Site Monopolar Cautery , 5mm, da Vinci Si Single-Site Fundus Grasper , 5mm, da Vinci Si IRIS System 1 CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100 12 mm Endoscope, 0° ASSY,CABLE,DOCO TO ILLUMINATOR 8.5 mm Endoscope, 0° DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR 12 mm Endoscope, 30° da Vinci Fluorescence Imaging Vision System DUCT,RIGHT,ILLUMINATOR,FIREFLY100 ASSY,CABLE,CORE TO DOCO STARTER KIT,FF100 VISION Camera Head Cable Fluorescence Imaging Illuminator Fluorescence Imaging Camera Head and Cable Kit DUCT,LEFT,ILLUMINATOR,FIREFLY100 8.5 mm Endoscope, 30° BRACKET(SET),DOCO/ILLUMINATOR RESTRAINING,IS3000 IS4000 Long Bipolar Forceps IS4000 Small Clip Applier IS4000 Long Bipolar Forceps Introducer 5Fr , 5mm, da Vinci S, Si EndoWrist Introducer Instrument Endoscopic Instruments Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree da Vinci Surgi=cal System, S (HD) ILLUMINATOR,Y1865 Harmonic Curved Shears, 5mm, da Vinci Harmonic Curved Shears, 8mm, da Vinci Harmonic Curved Shears Instrument Harmonic Curved Shears Harmonic Curved Shears, 8mm, da Vinci S, Si Harmonic Curved Shears Insert, da Vinci, da Vinci S, Si Harmonic Curved Shears, 5mm, da Vinci S, Si EndoWrist Stapler 45 Reload, Blue EndoWrist Stapler Motor Pack EndoWrist Stapler 45 Reload, Green EndoWrist Stapler 45 EndoWrist Stapler Cannula Seal EndoWrist Stapler Release Kit EndoWrist Stapler Sheath EndoWrist Stapler Cable INTUITIVE SURGICAL STEREO ENDOSCOPE 8mm Monopolar Curved Scissors da Vinci SonicPro Cleaning System EndoWrist Suction Irrigator 12mm IS4000 Endoscopes and Accessories Alignment Target, 8.6mm Endoscope 8.5mm Endoscope, 30° Cannula, 8.5mm Endoscope 8.5mm Endoscope, 0° CAMERA STARTER KIT,PANASONIC,HD STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2 STARTER KIT,IS3000,HD ENDOSCOPE,12MM Monopolar Curved Scissors , 8mm, da Vinci S, Si IS Endoscopic Instruments IS da Vinci Surgical System Tip Cover Accessory, da Vinci, da Vinci S, Si Monopolar Curved Scissors , 8mm, da Vinci Green System Cable, da Vinci Si 12 mm Endoscope Cannula Mount, COV, da Vinci 8 mm Cannula with Outlet, da Vinci S, Si Power Cord, 3.7 Meter, 115V, US, C13 > Hospital Grade Bipolar Energy Activation Cable, Gyrus ACMI, da Vinci, da Vinci S Blue System Cable, da Vinci Si Camera Starter Kit, PAL Wide Angle, Type 2 5 mm Sharp Obturator, da Vinci S, Si Tenaculum Forceps , 8mm, da Vinci S, Si Medium-Large Clip Applier , 8mm, da Vinci S, Si Accessory Base Starter Kit PreCise Bipolar Forceps , 8mm, da Vinci S, Si Camera Starter Kit, Panasonic HD Endowrist Permanent Cautery Instrum Light Guide Cable Adapter Cannula Holder, Twist¿Lock, da Vinci 8 mm Cannula with Outlet, Long, da Vinci S, Si Camera Head Video Cable, Panasonic® HD Camera Head Sterile Adapter Resano Forceps , 8mm, da Vinci S, Si 8 mm Blunt Obturator, da Vinci S, Si Curved Scissors , 5mm, da Vinci S, Si Valve Hook , 8mm, da Vinci S, Si Snap-fit Blue Blade, da Vinci, da Vinci S, Si Large SutureCut Needle Driver , 8mm, da Vinci S, Si Camera Arm Sterile Adapter 8 mm to 5 mm Cannula Reducer, da Vinci Long Tip Forceps , 8mm, da Vinci S, Si Permanent Cautery Hook , 8mm, da Vinci S, Si EndoWrist Permanent Cautery Instruments Red System Cable, da Vinci® S¿, da Vinci S 8 mm Instrument Cannula, Long, da Vinci S, Si Maryland Dissector , 5mm, da Vinci S, Si Round Tip Scissors , 5mm, da Vinci S, Si Cautery Spatula Tip, 5mm, da Vinci, da Vinci S, Si Black Diamond Micro Forceps , 8mm, da Vinci S, Si Dual Blade Retractor , 8mm, da Vinci S, Si Needle Driver , 5mm, da Vinci S, Si Schertel Grasper , 5mm, da Vinci S, Si Atrial Retractor Short Right , 8mm, da Vinci S, Si Potts Scissors , 8mm, da Vinci S, Si Bipolar Energy Activation Cable, CONMED, da Vinci, da Vinci S 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si Assembly, VSC, VS2000 Panasonic HD, Domestic 8 mm Instrument Cannula, da Vinci S, Si Monopolar Cautery , 5mm, da Vinci S, Si Small Clip Applier , 8mm, da Vinci S, Si Monopolar Energy Activation Cable, ERBE EndoWrist Stapler Cannula Blunt Obturator, da Vinci S, Si Assembly, Patient Side Cart EndoWrist Stapler Cannula Reducer, da Vinci S, Si Assembly, Vision System Assembly, Surgeon Side Console Bipolar Energy Activation Cable, CONMED EndoWrist Stapler Cannula, da Vinci S, Si Bipolar Energy Activation Cable, ERBE Energy Activation Cable, Ethicon Bipolar Energy Activation Cable, Gyrus ACMI Bipolar Energy Activation Cable, Valleylab da Vinci Surgical System, S Endowrist Bipolar Instruments Endowrist Instruments 3D Camera, Wide Angle, NTSC Cleaning and Sterilization Kit, English 12 mm Endoscope Cannula Mount, Balloon Port Camera Head Video Cable, Ikegami® HD 3DHD Camera Head and Cable (Panasonic HD) Camera Head Video Cable, Sumitomo® SD Fiber Cable Cleaning Kit Monopolar Energy Activation Cable, CONMED, da Vinci, da Vinci S 3D Camera, Wide Angle, PAL da Vinci® 8 mm Cannula Gage Pin, da Vinci, da Vinci S, Si Permanent Cautery Spatula , 8mm, da Vinci S, Si Assembly, PSCart, IS2000, 4-Arm, G1.1 Light Guide Cable Adapter, da Vinci, da Vinci S 8 mm Sharp Obturator, Long, da Vinci S, Si Micro Bipolar Forceps, 8mm, da Vinci S, Si Fenestrated Bipolar Forceps , 8mm, da Vinci S, Si Small Grasping Retractor , 8mm, da Vinci S, Si 12 mm Endoscope Cannula Mount, COV Illuminator Lamp Module, Model Y1866 8 mm Cannula Seal, da Vinci, da Vinci S, Si 8 mm Sharp Obturator, da Vinci S, Si DeBakey Forceps , 5mm, da Vinci S, Si Cobra Grasper , 8mm, da Vinci S, Si Grasping Retractor , 8mm, da Vinci S, Si Large Clip Applier , 8mm, da Vinci S, Si 12 mm Endoscope Cannula Mount, ETH, da Vinci 8 mm to 5 mm Cannula Reducer, da Vinci S, Si Monopolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S 5 mm Blunt Obturator, da Vinci S, Si Thoracic Grasper , 8mm, da Vinci S, Si Thoracic Grasper , 5mm, da Vinci S, Si Snap-fit Paddle Blade, da Vinci, da Vinci S, Si Assembly, Vision System w/TS, NTSC, VS2000 HD, Domestic Assembly, Cannula Mount, Dual Jaw COV, ECM, da Vinci S, Si Bipolar Energy Activation Cable, ERBE, da Vinci, da Vinci S 12 mm Endoscope Cannula Mount, ETH/TAUT, da Vinci S, Si Bifurcated Light Guide Assembly, Surgeon Side System, IS2000 Cautery Hook Tip, 5 mm, da Vinci, da Vinci S, Si Round Tip Scissors , 8mm, da Vinci S, Si Cadiere Forceps , 8mm, da Vinci S, Si Curved Bipolar Dissector , 8mm, da Vinci S, Si 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si Large Needle Driver , 8mm, da Vinci S, Si Camera Starter Kit, NTSC Wide Angle, Type 2 Monopolar Energy Activation Cable, ERBE, da Vinci, da Vinci S DeBakey Forceps , 8mm, da Vinci S, Si Maryland Bipolar Forceps , 8mm, da Vinci S, Si 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci Cannula 5 mm Regular, da Vinci S, Si 8 mm Blunt Obturator, Long, da Vinci S, Si Snap-Fit Scalpel Instrument , 8mm, da Vinci S, Si Mega Needle Driver , 8mm, da Vinci S, Si Mega SutureCut Needle Driver , 8mm, da Vinci S, Si 12 mm Instrument Cannula, da Vinci S, Si Prograsp Forceps , 8mm, da Vinci S, Si Bowel Grasper , 5mm, da Vinci S, Si Bipolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S Double Fenestrated Grasper , 8mm, da Vinci S, Si Camera Starter Kit, PAL High Mag, Type 2 12 mm Blunt Obturator, da Vinci S, Si Curved Scissors , 8mm, da Vinci S, Si Monopolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S Accessory Base Starter Kit, Multi-Specialty, ETH 3DHD Camera Head and Cable (Ikegami HD) Bipolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM Reprocessing Cover Catheter Guide Leak Test Adapter Controller Vision Probe Adapter and Suction Adapter Catheter Continuity Cable Ion™ Fully Articulating Catheter Flexision™ Biopsy Needle 23G Ion™ Peripheral Vision Probe PlanPoint™ Software Catheter Continuity Stand Flexision™ Biopsy Needle 21G Bath Probe Planning Laptop Swivel Connector System Cart Flexision™ Biopsy Needle 19G Ion Reprocessing Consumable Kit Intuitive Surgical EndoWrist Stabilizer Dual Blade Retractor , 8mm, da Vinci Atrial Retractor , 8mm, da Vinci EndoWrist Endoscopic Instruments Round Tip Scissors , 5mm, da Vinci DeBakey Forceps , 5mm, da Vinci Maryland Dissector , 5mm, da Vinci Schertel Grasper , 5mm, da Vinci Pericardial Dissector , 8mm, da Vinci Thoracic Grasper , 8mm, da Vinci Needle Driver , 5mm, da Vinci Resano Forceps , 8mm, da Vinci Fine Tissue Forceps , 8mm, da Vinci 12 Mm & Stapler Bladeless Obturator Monopolar Cautery Cord Bipolar Cautery Cord 8mm Large Needle Driver 8mm Long Bipolar Grasper 8mm Cadiere Forceps 8mm Cobra Graspers 8mm Maryland Bipolar Forceps 8mm Curved Bipolar Dissector 8mm Mega SutureCut Needle Driver 8mm Long Tip Forceps 8mm Micro Bipolar Forceps 8mm Large SutureCut Needle Driver 8mm ProGrasp Forceps 8mm Force Bipolar 8mm Fenestrated Bipolar Forceps PROBE HOLDER SYSTEM Harmonic Ace Curved Shears , 8mm, da Vinci S, Si Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si Harmonic Ace Curved Shears , 5mm, da Vinci Harmonic Ace Curved Shears , 5mm, da Vinci S, Si 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000) Harmonic Ace Curved Shears Fenestrated Bipolar Forceps, 5mm, da Vinci Si Stapler-8mm Cannula Reducer EndoWrist® Stapler 45 Stapler Cannula Blunt Obturator Stapler 45 Reload, White Stapler 45 Reload, Green Stapler Cannula, Long Stapler Cannula Blunt Obturator, Long Stapler 45 Reload, Blue Stapler Cannula Stapler Release Kit Stapler Sheath 10-12mm+Stapler Cannula Seal EndoWrist® Stapler 45 Curved-Tip EndoWrist Stapler System Starter Kit - 45 mm SRK,ENGLISH,IS4000 EndoWrist Stapler Cannula Kit EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees Da Vinci X/Xi 8mm Endoscope Plus, 0 degree IS4000 da Vinci EndoWrist Instruments 8mm Cobra Grasper 8mm Debakey Forceps 8mm Round Tip Scissor Force Bipolar 8 mm Bladeless Obturator (Optical) 8 mm Bladeless Obturator (Optical), Long Cannula Seal, 8mm Energy Activation Cable, CONMED, da Vinci Si CABLE,PMED,COVIDIEN FORCE TRIAD Energy Activation Cable, ERBE, da Vinci Si Energy Activation Cable, Gyrus, da Vinci Si Energy Activation Cable, Ethicon, da Vinci Si Energy Activation Adapter, Ethicon GEN11, da Vinci Si VIO-ICB Mounting Bracket Option, Connect, da Vinci Si da Vinci Surgical System, Si KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F Camera Starter Kit ASSY,VSS VISION SYSTEM W/AVP,VS3000 CABLE KIT,BLUE FIBERCONNECT,20M ASSY,PSCART,IS3000,4-ARM 3DHD Camera Head and Cable ASSY,SSC,IS3000 VisionBoom¿ Extension Cable Energy Activation Cable, Valleylab, da Vinci Si ASSY,PSCART,IS3000,3-ARM SP Cleaning and Sterilization Kit, da Vinci SP Endowrist Stapler Obturator Endowrist Stapler Cannula Endowrsit Stapler Reducer EndoWrist Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci S, Si Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci Tip Cover Accessory Ion Endoluminal System (IF1000) Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si EndoWrist Stapler 30 Instrument Curved Stapler 30 EndoWrist Stapler 30 Reloads EndoWrist Vessel Sealer Extend PK® Instrument Cord, G400 Generator, da Vinci, da Vinci S, Si EndoWrist PK Dissecting Forceps PK Dissecting Forceps PK Dissecting Forceps , 8mm, da Vinci S, Si PK® Instrument Cord, PK/SP Generator, da Vinci, da Vinci S, Si da Vinci X Surgical System da Vinci Xi Surgical System with Table Motion da Vinci Xi Surgical System, Patient Cart da Vinci Xi Surgical System, Vision Cart da Vinci Xi Surgical System, Surgeon Console 8mm Micro Bipolar Forceps, Xi Endoscope, 0 degrees, Xi 8mm Monopolar Curved Scissors, Xi 8mm Large Needle Driver, Xi 8mm Fenstrated Bipolar Forceps, Xi 8mm Cardiac Probe Grasper, Xi 8mm Potts Scissors, Xi 8mm Mega SutureCut Needle Driver, Xi 8mm Long Tip Forceps, Xi 8mm Medium Large Hem-O-Lok Clip Applier 8mm Resano Forceps, Xi 8mm Tip-Up Fenstrated Grasper, Xi 8mm Atrial Retractor Short Right, Xi 8mm Small Clip Applier, Xi Gage Pin, Xi 8mm Large Suturecut Needle Driver, Xi 8mm Blunt Obturator, Xi 8mm Instrument Introducer, Xi 8mm Dual Blade Retractor, Xi 8mm Maryland Bipolar Forceps, Xi 8mm Large Hem-O-Lok Clip Applier, Xi Endoscope, 30 degrees, Xi 8mm Blunt Obturator Long, Xi 8mm Small Grasping Retractor, Xi IRK,ENGLISH,IS4000 8mm Cannula Long, Xi 8mm Black Diamond Micro Forceps, Xi 8mm Flared Cannula, Xi 8mm ProGrasp Forceps, Xi 8mm Cannula Standard, Xi 8mm Snap-Fit Instrument, Xi Instrument Release Kit, Xi 8mm Medium-Large Clip Applier, Xi 8mm Permanent Monopolar Cautery Hook, Xi 8mm Permanent Monopolar Cautery Spatula, Xi 8mm Tenaculum Forceps, Xi Cleaning and Sterilization Kit da Vinci Single-Site Instrument and Accessories 8 mm Trocar, Long 5 mm to 8 mm Cannula Seal 8 mm Trocar, Standard IS Endowrist Bipolar Instrument Micro Bipolar Forceps , 8mm, da Vinci PreCise Bipolar Forceps , 8mm, da Vinci Universal Seal (5-12 mm) EndoWrist One Vessel Sealer, 8mm, da Vinci Si Valve Hook , 8mm, da Vinci Curved Scissors , 5mm, da Vinci Blade Protector, Snap-fit, da Vinci, da Vinci S, Si Monopolar Cautery , 5mm, da Vinci Mega SutureCut Needle Driver , 8mm, da Vinci IS Endoscopic Control System Bowel Grasper , 5mm, da Vinci Snap-Fit Scalpel Instrument , 8mm, da Vinci surgical drapes Handheld Camera Light Guide Adapter Handheld Camera Light Guide Da Vinci Handheld Camera Handheld Camera Sterilization Tray EndoWrist 5mm Thoracic Grasper Ion reprocessing accessory kit

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device