FDA Registration Active 🇺🇸 United States

INTUITIVE SURGICAL, INC.

Reg #: 3015612252 · FEI: 3015612252 · Expires 2026
Products
28
Proprietary Names
616
Establishment Types
2
Classifications
28

Registration Details

Registration Name
INTUITIVE SURGICAL, INC.
Registration Number
3015612252
FEI Number
3015612252
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
3410 Central Expressway, --
City
Santa Clara
State
CA
ZIP
95051
Country
US

Regulatory Submissions

510(k) Number
K231224

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
System, Surgical, Computer Controlled Instrument NAY
Electrosurgical, Cutting & Coagulation & Accessories GEI
Unit, Cryosurgical, Accessories GEH
Staple, Implantable GDW
Confocal Optical Imaging OWN
Laparoscope, General & Plastic Surgery GCJ
Stand, Infusion FOX
Bronchoscope (Flexible Or Rigid) EOQ
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Washer, Cleaner, Automated, Endoscope NVE
Accessories, Cleaning Brushes, For Endoscope MNL
System, X-Ray, Angiographic IZI
Stapler, Surgical GAG
Light Source, Fiberoptic, Routine FCW
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
Laparoscopy Kit FDE
Source, Carrier, Fiberoptic Light EQH
Drape, Surgical, Antimicrobial KKX
Laryngoscope, Endoscope GCI
System, Image Processing, Radiological LLZ
Automated Radiological Image Processing Software QIH
Drape, Surgical, Exempt PUI
Insufflator, Laparoscopic HIF
Instrument, Ultrasonic Surgical LFL
Drape, Surgical, Ent ERY
Led Light Source NTN
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Cannula, Manipulator/Injector, Uterine LKF

Proprietary Names

da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200 da Vinci Xi Surgical System (IS4000) da Vinci X Surgical System (IS4200) da Vinci Single-Site Accessories 8 mm Harmonic ACE Curved Shears EndoWrist Vessel Sealer da Vinci Single-Site Instruments Endoscopic Instruments EndoWrist Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci S, Si Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci SureForm 45 Curved Tip, SureForm 45 Gray Reload EndoWristStapler 30 and Stapler 30Reloads EndoWristStapler 45 and Stapler 45 Reloads Da Vinci Monopolar and Bipolar Adapters 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® da Vinci® Fluorescence Imaging Vision System EndoWrist 5mm Thoracic Grasper 8 mm Assist Cannula 12 mm Assist Cannula CIM pivot arm CIM extended height adjustable arm CIM height adjustable arm CIM extended pivot arm Roll stands and charts da Vinci SP Surgical System 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 da Vinci X Surgical System Ion Endoluminal System (IF1000) da Vinci Force Feedback ProGrasp Forceps da Vinci Force Feedback Large Needle Driver da Vinci Force Feedback Cadiere Forceps da Vinci Force Feedback Mega SutureCut Needle Driver da Vinci Force Feedback Maryland Bipolar Forceps da Vinci Force Feedback Fenestrated Bipolar Forceps Cannula Seal, 8mm Energy Activation Cable, CONMED, da Vinci Si CABLE,PMED,COVIDIEN FORCE TRIAD Accessory Base Starter Kit 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 12 mm Endoscope, 0° 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 12 mm Endoscope, 30° Endoscope Sterilization Tray INTUITIVE SURGICAL STEREO ENDOSCOPE da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 MARS 1 Streme App Universal Seal (5-12 mm) NIR Handheld Camera Tray Ion™ Peripheral Vision Probe Ion™ Fully Articulating Catheter Reprocessing Cover EndoWrist Stapler 30 Instrument Curved Stapler 30 EndoWrist Stapler 30 Reloads DEVICE,ENERGY,ERBE VIO 300D 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 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 CAMERA STARTER KIT,PANASONIC,HD STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2 IS4200 ACCESSORY STARTER KIT STARTER KIT,IS3000,HD ENDOSCOPE,12MM IS4000 ACCESSORY STARTER KIT da Vinci Xi da Vinci X da Vinci SP Surgical System, Vision Cart da Vinci SP Surgical System, Patient Cart da Vinci SP Surgical System, Surgeon Console Intuitive Surgical da Vinci Surgical System EndoWrist Stabilizer da Vinci S Surgical System Da Vinci E-200 Generator da Vinci E-200 Electrosurgical Generator MP Instrument Reprocessing Connector, 2 Device MP Instrument Reprocessing Connector, 1 Device IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000 Force Bipolar Da Vinci E200 Generator Da Vinci SP Vision Cart da Vinci Xi Surgical System with Table Motion Endopass Delivery Instrument EndoPass Endoscopic Delivery Instruments Intuitive Surgical da Vinci S Surgical System, Model IS2000 with Connect OnSite and Wireless Connectivity Option SP Cleaning and Sterilization Kit, da Vinci SP Intuitive Surgical EndoWrist Stabilizer 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 da Vinci Xi 12-8 mm Reducer 12 Mm & Stapler Bladeless Obturator Medium-Large Clip Applier, da Vinci SP Instrument Arm Drape, da Vinci SP EnergyShield Monopolar Cautery Cord, da Vinci SP Cautery Spatula Tip, da Vinci SP Bipolar Cautery Cord, da Vinci SP Cautery Hook Tip, da Vinci SP EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP Fenestrated Bipolar Forceps, da Vinci SP Cleaning and Sterilization Kit, da Vinci SP Monopolar Cautery Instrument, da Vinci SP Maryland Bipolar Forceps, da Vinci SP Cadiere Forceps, da Vinci SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP MCS Tip, da Vinci SP Needle Driver, da Vinci SP Camera Sheath, da Vinci SP Monopolar Curved Scissors, da Vinci SP EndoWrist SP Camera, 0 degree, da Vinci SP Round Tooth Retractor, da Vinci SP Instrument Sheath, da Vinci SP SP Access Port Kit, Small Incision (2.7 cm-4 cm) SP Access Port Kit, Large Incision (2.7 cm-7 cm) 8mm Monopolar Curved Scissors Valve Hook , 8mm, da Vinci IS Endoscopic Instruments 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 da Vinci SP Firefly Imaging System EndoWrist Stapler 45 System 8 mm SureForm 30 System SureForm 45 System SureForm 60 System EndoWrist Stapler 30 System Da Vinci Force Feedback Cadiere Forceps Da Vinci Force Feedback Mega SutureCut Needle Driver Da Vinci Force Feedback Maryland Bipolar Forceps Da Vinci Force Feedback Fenestrated Bipolar Forceps Da Vinci Force Feedback Large Needle Driver Da Vinci Force Feedback ProGrasp Forceps EndoWrist Suction Irrigator NIR Handheld Camera Light Source NIR Handheld Camera NIR Handheld Camera Control Unit (CCU) Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si NIR Handheld Camera System Starter Kit Da Vinci 5 Tower - Model: T5000 Da Vinci 5 Robot - Model: R5000 Da Vinci 5 Console - Model: C5000 Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree Intuitive Surgical Vessel Sealer Extend 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 da Vinci SP Surgical System (SP1098) VIO DV 2,INTEGRATED ELECTRO SURGICAL UNIT da Vinci Single-Site Instrument and Accessories SRK,OUS,IS4000 NIR Handheld Camera Light Guide Automated Reprocessing Connector Set, 8mm Endoscope, Xi SP Reprocessing Connector, 2 devices SP Instrument Reprocessing Tray MP Instrument Reprocessing Tray SP Reprocessing Connector, 1 device SP Endoscope Reprocessing Tray AUTOMATED REPROCESSING CONNECTOR SET,8MM ENDOSCOPE,IS4000 Cleaning and Disinfection Tray, Catheter and Vision Probe, IF1000 da Vinci Instrument Reprocessing Tray Universal Seal (5-12mm) Fenestrated Bipolar Forceps, 5mm, da Vinci Si IS Endowrist Bipolar Instrument Micro Bipolar Forceps , 8mm, da Vinci PreCise Bipolar Forceps , 8mm, da Vinci 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 Alignment Target, 8.6mm Endoscope 8.5mm Endoscope, 30° Cannula, 8.5mm Endoscope 8.5mm Endoscope, 0° Handheld Camera Light Guide Adapter Handheld Camera Light Guide Da Vinci Handheld Camera Handheld Camera Sterilization Tray ICB, Instrument Control Box EndoWrist One Vessel Sealer, 8mm, da Vinci Si da Vinci SonicPro Cleaning System EndoWrist Accessories, da Vinci Xi EndoWrist Instruments, da Vinci Xi IRISeg Introducer 5Fr , 5mm, da Vinci S, Si EndoWrist Introducer Instrument 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 IRK,OUS,IS4000 IRK,OUS,IS3000 IRK,OUS,W/O VS,IS3000 IRK,OUS,W/O VS,IS4000 PANASONIC CAMERA HEAD,HDTV,SCHOELLY Vision Probe Bag CAMERA ARM DRAPE,IS3000 INSTRUMENT ARM DRAPE IS2000 COLUMN DRAPE, IS4000 ARM 4 PROXIMAL DRAPE, IS4200 INSTRUMENT ARM DRAPE, IS4000 SP Monopolar Curved Scissors Extended Range SP Monopolar Cautery Instrument SP Medium Large Clip Applier SP Needle Driver Extended Range SP Force Bipolar SP Needle Driver SP Monopolar Curved Scissors SP Cadiere Forceps SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments) SP Maryland Bipolar Forceps SP Cadiere Forceps, Extended Range SP Round Tooth Retractor Extended Range SP Maryland Bipolar Forceps, Extended Range SP Fenestrated Bipolar Forceps SP Force Bipolar, Extended Range 8 mm SureForm 30 Stapler 8 mm SureForm 30 Reload, White 8 mm SureForm 30 Curved-Tip Stapler 8 mm SureForm 30 Reload, Blue 8 mm SureForm 30 Reload, Gray da Vinci Insufflator Tube Set with Smoke Evacuation 8mm Endoscope, 30°, Gen5 Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5 8mm Hex Cannula, Standard 8mm Hex Cannula, Long da Vinci 5 Force Feedback Fenestrated Bipolar Forceps Blue System Cable, Type B, 7m da Vinci 5 Force Feedback Maryland Bipolar Forceps UPGRADE,CO2 TANK INTERFACE,CGA940,US Double Receptacle System Cable Extension Kit da Vinci 5 Force Feedback Cadiere Forceps da Vinci 5 Force Feedback Large Needle Driver Single Receptacle System Cable Extension Kit da Vinci 5 Force Feedback Mega SutureCut Needle Driver da Vinci Insufflator da Vinci 5 Force Feedback ProGrasp Forceps 8mm Endoscope, 0°, Gen5 da Vinci Surgical System (IS5000) EndoWrist One Vessel Sealer , 8mm, da Vinci Si Da Vinci E-200 Electrosurgical Generator CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100 ASSY,CABLE,DOCO TO ILLUMINATOR 8.5 mm Endoscope, 0° DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR 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 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 SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP Blue System Cable, Type A to Type B, 7m Harmonic ACE Intuitive Surgical da Vinci®,da Vinci S®, and da Vinci Si® Surgical Systems and EndoWrist Instruments and Accessories da Vinci Surgi=cal System, S (HD) ILLUMINATOR,Y1865 Monopolar Curved Scissors , 8mm, da Vinci S, Si IS da Vinci Surgical System Tip Cover Accessory, da Vinci, da Vinci S, Si Monopolar Curved Scissors , 8mm, da Vinci 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 Universal Seal Ion reprocessing accessory kit Tip Cover Accessory da Vinci Si da Vinci SP SureForm™ 45 Curved-Tip Stapler da Vinci SP SureForm™ 45 Stapler 8.5-13 mm Cannula Seal Fluorescence Imaging Kit 8mm 0 degree endoscope 8mm 30 degree endoscope Xi X Monopolar Curved Scissors, 8mm, da Vinci S, Si Ion™ Endoluminal System, Model IF1000 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 5 mm Flared Cannula, da Vinci S, Si STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) da Vinci Firefly Imaging System EndoWrist One Suction/Irrigator, 8mm, da Vinci Si EndoWrist One Suction/Irrigator IS4000 Long Bipolar Forceps IS4000 Small Clip Applier IS4000 Long Bipolar Forceps IS3000 Stapler 45 Instrument IS4000 EndoWrist Stapler 30 IS3000 Stapler 45 Accessories IS4000 Stapler 45 Accessories IS4000 Stapler 45 Instrument surgical drapes 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 SP Endoscope, 0° NIR Handheld Camera Light Guide Adapter da Vinci Xi 8 mm Hasson Cone da Vinci Xi 12 mm and Stapler Hasson Cone IRIS System 1 SureForm 60 Reloads SureForm 60 Catheter Guide Leak Test Adapter Controller Vision Probe Adapter and Suction Adapter Catheter Continuity Cable Flexision™ Biopsy Needle 23G 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 PROBE HOLDER SYSTEM Laparoscope 5mm, 0 Laparoscope 5mm, 30 Laparoscope 10mm, 0, NIR Laparoscope 10mm, 30, NIR 8mm SureForm Stapler 8mm SureForm Reloads 8mm SureForm 30 Curved-Tip Stapler SureForm 45, SureForm 45 Reloads iESU 8 mm Trocar, Long 5 mm to 8 mm Cannula Seal 8 mm Trocar, Standard 8 mm Bladeless Obturator (Optical) 8 mm Bladeless Obturator (Optical), Long IS4000 da Vinci EndoWrist Instruments 8mm Cobra Grasper 8mm Debakey Forceps 8mm Round Tip Scissor da Vinci SP Advanced Access Port Kit 3D Model Viewer Video Review (also referred to as “Replay”) EndoWrist Instruments, da Vinci S/Si Monopolar Cautery Cord Bipolar Cautery Cord Teleflex Obturators Harmonic ACE Curved Shears, 5mm, da Vinci S/Si EndoWrist resuable Accessories, da Vinci S/Si Harmonic ACE Curved Shears, 8mm, da Vinci S/Si Endowrist Stapler Obturator Endowrist Stapler Cannula Endowrsit Stapler Reducer EndoWrist Vessel Sealer Extend E-100 SynchroSeal Ion" Peripheral Vision Probe Flexision" Biopsy Needle 19G Ion" Fully Articulating Catheter Flexision" Biopsy Needle 21G Flexision" Biopsy Needle 23G PlanPoint" Software 12mm IS4000 Endoscopes and Accessories Endoscopes, da Vinci S/Si Endoscopes, da Vinci Xi

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only