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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2015-04-23 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2019-02-22 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2019-02-22 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2014-08-14 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2015-04-13 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2020-02-26 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2014-06-18 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2020-11-05 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-02-27 |
| Washer, Cleaner, Automated, Endoscope | NVE | Class 2 | Gastroenterology, Urology | No | 2008-10-02 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2019-02-27 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2007-11-26 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2018-08-17 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2009-12-10 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2018-08-21 |
| Drape, Surgical, Ent | ERY | Class 2 | General, Plastic Surgery | No | 2017-06-02 |
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