Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- GCILaryngoscope, Endoscope2Product Code
- GCJLaparoscope, General & Plastic Surgery2Product Code
- MFJDevice, Endoscopic Suturing2Product Code
- EPYSpeculum, Ent1Product Code
- NAYSystem, Surgical, Computer Controlled Instrument2Product Code
- K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator2Cleared 510(K)
- K251739da Vinci Surgical System (IS5000)2Cleared 510(K)
- K252675da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K252069da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K251426da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K251817da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K251227da Vinci Surgical System (IS5000)2Cleared 510(K)
- K251324da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K252350da Vinci SP Firefly Imaging System2Cleared 510(K)
- K250442da Vinci Surgical System, IS50002Cleared 510(K)
- K251213Da Vinci Surgical System (IS5000)2Cleared 510(K)
- K251202da Vinci Surgical System (IS5000)2Cleared 510(K)
- K250674Vessel Sealer Curved (480522)2Cleared 510(K)
- K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)2Cleared 510(K)
- K250786SP Endoscope, 0° (430600)2Cleared 510(K)
- K243714da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)2Cleared 510(K)
- K243582da Vinci SP Advanced Access Port Kit (432701)2Cleared 510(K)
- K243641da Vinci Surgical System (IS5000)2Cleared 510(K)
- K242318da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K241814da Vinci SP Instruments (SP1098)2Cleared 510(K)
- K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads2Cleared 510(K)
- K233866Senhance Surgical System2Cleared 510(K)
- K240502da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K241284da Vinci Surgical System (IS5000)2Cleared 510(K)
- K232773da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)2Cleared 510(K)
- K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation2Cleared 510(K)
- K231798da Vinci SP Surgical System2Cleared 510(K)
- K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)2Cleared 510(K)
- K230033Da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K223095Senhance Surgical System2Cleared 510(K)
- K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System2Cleared 510(K)
- K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)2Cleared 510(K)
- K222827da Vinci Firefly Imaging System2Cleared 510(K)
- K214095da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments2Cleared 510(K)
- K220889Senhance Surgical System2Cleared 510(K)
- K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System2Cleared 510(K)
- K2200238mm Monopolar Curved Scissors2Cleared 510(K)
- K2119978 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads2Cleared 510(K)
- K212101da Vinci SP Firefly Imaging System2Cleared 510(K)
- K212747Da Vinci SP Surgical System2Cleared 510(K)
- K212054Senhance Surgical System2Cleared 510(K)
- K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)2Cleared 510(K)
- K211325Senhance Surgical System2Cleared 510(K)
- K211316da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K211595da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System2Cleared 510(K)
- K202166Senhance Surgical System2Cleared 510(K)
- K203632da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments2Cleared 510(K)
- K202968Da Vinci SP Surgical System2Cleared 510(K)
- K200473SoloAsisst II, Voice Control2Cleared 510(K)
- K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)2Cleared 510(K)
- K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories2Cleared 510(K)
- K192717da Vinci SP Surgical System2Cleared 510(K)
- K192803da Vinci Xi Surgical System, da Vinci X Surgical System2Cleared 510(K)
- K183086da Vinci X and Xi Surgical System2Cleared 510(K)
- K200049Senhance Surgical System2Cleared 510(K)
- K191529da Vinci Xi Surgical System, da Vinci X Surgical System2Cleared 510(K)
- K192877Senhance Surgical System2Cleared 510(K)
- K191280E-100 Electrosurgical Generator, SynchroSeal2Cleared 510(K)
- K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 302Cleared 510(K)
- K190999SureForm 45 Curved Tip, SureForm 45 Gray Reload2Cleared 510(K)
- K191482Senhance Surgical System2Cleared 510(K)
- K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories2Cleared 510(K)
- K183224SureForm 45, SureForm 45 Reloads2Cleared 510(K)
- K182421Senhance Ultrasonic System2Cleared 510(K)
- K183107Intuitive Surgical Vessel Sealer Extend2Cleared 510(K)
- K183098Senhance Surgical System2Cleared 510(K)
- K182140da Vinci Xi Surgical System, da Vinci X Surgical System2Cleared 510(K)
- K181517Senhance Surgical System2Cleared 510(K)
- K171947SOLOASSIST II2Cleared 510(K)
- K180351EndoWrist Mercury Bipolar Grasper2Cleared 510(K)
- K173585da Vinci Xi Surgical System, da Vinci X Surgical System2Cleared 510(K)
- K173721SureForm 60 and SureForm 60 Reloads2Cleared 510(K)
- K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories2Cleared 510(K)
- K173415EndoWrist 5mm Thoracic Grasper2Cleared 510(K)
- K180163TransEnterix Senhance Surgical System2Cleared 510(K)
- K173337Intuitive Surgical EndoWrist Vessel Sealer Extend2Cleared 510(K)
- K173842da Vinci Xi Surgical System, da Vinci X Surgical System2Cleared 510(K)
- K1800338mm Monopolar Curved Scissors2Cleared 510(K)
- K172643da Vinci Xi Surgical System; da Vinci X Surgical System2Cleared 510(K)
- K171120Senhance Surgical Robotic System2Cleared 510(K)
- K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories2Cleared 510(K)
- K170641da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes2Cleared 510(K)
- K171632da Vinci Xi Surgical System2Cleared 510(K)
- K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories2Cleared 510(K)
- K170644da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)2Cleared 510(K)
- K170645da Vinci Xi EndoWrist Instruments and Accessories2Cleared 510(K)
- K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System2Cleared 510(K)
- K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree2Cleared 510(K)
- K170713da Vinci Xi Surgical System2Cleared 510(K)
- K171388EndoWrist Stapler 45 System and Stapler 45 Reloads2Cleared 510(K)
- K171294da Vinci X Surgical System2Cleared 510(K)
- K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories2Cleared 510(K)
- K170508EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads2Cleared 510(K)
- K162973EndoWrist Suction Irrigator2Cleared 510(K)
- K161178da Vinci Xi Surgical System2Cleared 510(K)
- K162411da Vinci Xi 12 – 8 mm Reducer2Cleared 510(K)
- K153276da Vinci Xi Surgical System2Cleared 510(K)
- K161271da Vinci Xi Surgical System2Cleared 510(K)
- K152892da Vinci Xi Surgical System2Cleared 510(K)
- K152578da Vinci Surgical System, Model IS40002Cleared 510(K)
- K152448da Vinci Single-Site Instrument and Accessories2Cleared 510(K)
- K152421IS4000 Stapler 30 Instrument and Stapler 30 Reloads2Cleared 510(K)
- K151794da Vinci Xi Surgical System2Cleared 510(K)
- K150284IS4000 da Vinci EndoWrist Instruments2Cleared 510(K)
- K150837IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps2Cleared 510(K)
- K143132IS4000 8mm Harmonic ACE Curved Shears2Cleared 510(K)
- K14268312 mm Endoscopes and Accessories2Cleared 510(K)
- K14321712 mm & Stapler Bladeless Obturators2Cleared 510(K)
- K141075SINGLE-SITE WRISTED NEEDLE DRIVER2Cleared 510(K)
- K123329DA VINVI SURGICAL SYSTEM2Cleared 510(K)
- K141077DA VINCI FIREFLY IMAGING SYSTEM2Cleared 510(K)
- K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS2Cleared 510(K)
- K140189ENDOWRIST VESSEL SEALER2Cleared 510(K)
- K131962DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES2Cleared 510(K)
- K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES2Cleared 510(K)
- K130266ENDOWRIST ONE VESSEL SEALER2Cleared 510(K)
- K122532DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES2Cleared 510(K)
- K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK2Cleared 510(K)
- K123840CONNECT FOR DA VINCI SURGICAL SYSTEM(S)2Cleared 510(K)
- K123463INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS2Cleared 510(K)
- K121921INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS2Cleared 510(K)
- K113706ENDOWRIST STAPLER SYSTEM2Cleared 510(K)
- K120215SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE2Cleared 510(K)
- K110639ENDOWRIST ONE VESSEL SEALER2Cleared 510(K)
- K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES2Cleared 510(K)
- K112263MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY2Cleared 510(K)
- K1125845MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT2Cleared 510(K)
- K110451ENDOWRIST ONE SUCTION/IRRIGATOR2Cleared 510(K)
- K101581INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS20002Cleared 510(K)
- K1017435MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 4203192Cleared 510(K)
- K0932175 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)2Cleared 510(K)
- K090993INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS30002Cleared 510(K)
- K082497INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT2Cleared 510(K)
- K081137INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS30002Cleared 510(K)
- K081207INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE2Cleared 510(K)
- K080291INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER2Cleared 510(K)
- K070947INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER2Cleared 510(K)
- K072627INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER2Cleared 510(K)
- K063220DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS20002Cleared 510(K)
- K061260INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 4202142Cleared 510(K)
- K060391INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 4201822Cleared 510(K)
- K050802MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS20002Cleared 510(K)
- K043288MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K050005INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 4001802Cleared 510(K)
- K043153INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS10002Cleared 510(K)
- K042855INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT2Cleared 510(K)
- K040237INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K040948INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 4001702Cleared 510(K)
- K030578BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM2Cleared 510(K)
- K022574INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/12002Cleared 510(K)
- K021152ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES2Cleared 510(K)
- K021036INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS10002Cleared 510(K)
- K012833INTUITIVE SURGICAL BIPOLAR FORCEPS2Cleared 510(K)
- K011281INTUITIVE SURGICAL ULTRASONIC SHEARS2Cleared 510(K)
- K011002INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 10002Cleared 510(K)
- K002489INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM2Cleared 510(K)
- K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM2Cleared 510(K)
- NEQDevice, Telemedicine, Robotic2Product Code
- PDTBurn Resuscitation Decision Support Software2Product Code
- FDPApparatus, Pneumoperitoneum, Automatic2Product Code
- GCGPeritoneoscope2Product Code
- GCHMediastinoscope, Diagnostic2Product Code
- OTJLaparoscopic Single Port Access Device2Product Code
- OWNConfocal Optical Imaging2Product Code
- QGYMobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera2Product Code
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)2Product Code
- POYPost Breast Biopsy Hemostatic Breast Compression Device2Product Code
- FXESpeculum, Non-Illuminated1Product Code
- FXFSpeculum, Illuminated1Product Code
- FXGSpecula Accessories1Product Code
- JYKHolder, Ear Speculum1Product Code
- KAGHolder, Speculum, Ent1Product Code
- QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured2Product Code
- QZBSoftware Controlled Endoscope And Instrument Holder2Product Code
- SFEEndoscopic Video Imaging System / Software Component For Real Time Video Augmentation2Product Code
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K240852
- 510(k) Type
- Traditional
- Applicant
- Intuitive Surgical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/11/2025
- Days to Decision
- 440 days
- Submission Type
- Summary