Company
Intuitive Surgical
Summary
- Sunnyvale, United States
- Stage: Public company
- Use: Civil
- Focus: Hardware-first
Fields
About
Makes the da Vinci surgical robots and the Ion robotic system for lung biopsy.
Machines
1On the map
Sources
159Independent reports1
Intuitive Surgical was founded in 1995.
WikidataUndated
Official filings158
FDA 510(k) clearance K261823: da Vinci Surgical System, Model IS5000
U.S. FDA8 Sept 2026FDA 510(k) clearance K261824: da Vinci Surgical System, Model IS5000
U.S. FDA31 Jul 2026FDA 510(k) clearance K260695: da Vinci Firefly Imaging System
U.S. FDA22 May 2026FDA 510(k) clearance K253986: da Vinci Force Feedback Instruments
U.S. FDA11 Mar 2026FDA 510(k) clearance K251739: da Vinci Surgical System (IS5000)
U.S. FDA16 Jan 2026
153 older official filings
FDA 510(k) clearance K253556: da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
U.S. FDA16 Jan 2026FDA 510(k) clearance K252675: da Vinci SP Surgical System (SP1098)
U.S. FDA15 Dec 2025FDA 510(k) clearance K252069: da Vinci SP Surgical System (SP1098)
U.S. FDA2 Dec 2025FDA 510(k) clearance K251426: da Vinci SP Surgical System (SP1098)
U.S. FDA3 Oct 2025FDA 510(k) clearance K252045: Ion Endoluminal System (IF1000)
U.S. FDA23 Sept 2025FDA 510(k) clearance K251817: da Vinci SP Surgical System (SP1098)
U.S. FDA10 Sept 2025FDA 510(k) clearance K251227: da Vinci Surgical System (IS5000)
U.S. FDA8 Sept 2025FDA 510(k) clearance K252528: Ion Endoluminal System (IF1000)
U.S. FDA5 Sept 2025FDA 510(k) clearance K251324: da Vinci SP Surgical System (SP1098)
U.S. FDA29 Aug 2025FDA 510(k) clearance K252350: da Vinci SP Firefly Imaging System
U.S. FDA28 Aug 2025FDA 510(k) clearance K250442: da Vinci Surgical System, IS5000
U.S. FDA29 Jul 2025FDA 510(k) clearance K251213: Da Vinci Surgical System (IS5000)
U.S. FDA23 Jul 2025FDA 510(k) clearance K251202: da Vinci Surgical System (IS5000)
U.S. FDA16 Jul 2025FDA 510(k) clearance K250674: Vessel Sealer Curved (480522)
U.S. FDA13 Jun 2025FDA 510(k) clearance K240852: da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
U.S. FDA11 Jun 2025FDA 510(k) clearance K250786: SP Endoscope, 0° (430600)
U.S. FDA13 May 2025FDA 510(k) clearance K243714: da Vinci SP Surgical System (SP1098)
U.S. FDA24 Apr 2025FDA 510(k) clearance K242427: da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
U.S. FDA1 Apr 2025FDA 510(k) clearance K243582: da Vinci SP Advanced Access Port Kit (432701)
U.S. FDA28 Feb 2025FDA 510(k) clearance K243641: da Vinci Surgical System (IS5000)
U.S. FDA16 Dec 2024FDA 510(k) clearance K242318: da Vinci SP Surgical System (SP1098)
U.S. FDA26 Nov 2024FDA 510(k) clearance K241814: da Vinci SP Instruments (SP1098)
U.S. FDA18 Nov 2024FDA 510(k) clearance K242070: Ion Endoluminal System (IF 1000)
U.S. FDA24 Sept 2024FDA 510(k) clearance K241638: 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
U.S. FDA10 Sept 2024FDA 510(k) clearance K240502: da Vinci SP Surgical System (SP1098)
U.S. FDA8 Jul 2024FDA 510(k) clearance K241284: da Vinci Surgical System (IS5000)
U.S. FDA3 Jul 2024FDA 510(k) clearance K232773: da Vinci SP Surgical System (SP1098)
U.S. FDA4 Jun 2024FDA 510(k) clearance K240723: da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
U.S. FDA24 May 2024FDA 510(k) clearance K240135: Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)
U.S. FDA3 Apr 2024FDA 510(k) clearance K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
U.S. FDA14 Mar 2024FDA 510(k) clearance K232984: Ion Endoluminal System (IF1000)
U.S. FDA18 Dec 2023FDA 510(k) clearance K231798: da Vinci SP Surgical System
U.S. FDA8 Nov 2023FDA 510(k) clearance K231224: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
U.S. FDA12 May 2023FDA 510(k) clearance K230033: Da Vinci SP Surgical System (SP1098)
U.S. FDA5 Apr 2023FDA 510(k) clearance K222839: EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
U.S. FDA16 Mar 2023FDA 510(k) clearance K223080: da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
U.S. FDA22 Nov 2022FDA 510(k) clearance K222827: da Vinci Firefly Imaging System
U.S. FDA20 Oct 2022FDA 510(k) clearance K214095: da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
U.S. FDA15 Aug 2022FDA 510(k) clearance K220299: Ion Endoluminal System (IF1000)
U.S. FDA16 Jun 2022FDA 510(k) clearance K213710: da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
U.S. FDA17 Feb 2022FDA 510(k) clearance K220023: 8mm Monopolar Curved Scissors
U.S. FDA31 Jan 2022FDA 510(k) clearance K211997: 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
U.S. FDA10 Dec 2021FDA 510(k) clearance K212101: da Vinci SP Firefly Imaging System
U.S. FDA23 Nov 2021FDA 510(k) clearance K212747: Da Vinci SP Surgical System
U.S. FDA29 Sept 2021FDA 510(k) clearance K212048: Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
U.S. FDA26 Aug 2021FDA 510(k) clearance K211784: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
U.S. FDA6 Aug 2021FDA 510(k) clearance K211316: da Vinci SP Surgical System (SP1098)
U.S. FDA23 Jul 2021FDA 510(k) clearance K211595: da Vinci SP Surgical System (SP1098)
U.S. FDA23 Jun 2021FDA 510(k) clearance K210918: da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
U.S. FDA26 Apr 2021FDA 510(k) clearance K203632: da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
U.S. FDA10 Feb 2021FDA 510(k) clearance K202968: Da Vinci SP Surgical System
U.S. FDA22 Dec 2020FDA 510(k) clearance K202834: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
U.S. FDA10 Dec 2020FDA 510(k) clearance K202370: Ion Endoluminal System
U.S. FDA16 Nov 2020FDA 510(k) clearance K202571: da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
U.S. FDA12 Nov 2020FDA 510(k) clearance K192717: da Vinci SP Surgical System
U.S. FDA28 Sept 2020FDA 510(k) clearance K201146: Ion Endoluminal System
U.S. FDA26 Jun 2020FDA 510(k) clearance K192803: da Vinci Xi Surgical System, da Vinci X Surgical System
U.S. FDA29 Apr 2020FDA 510(k) clearance K183086: da Vinci X and Xi Surgical System
U.S. FDA31 Mar 2020FDA 510(k) clearance K191529: da Vinci Xi Surgical System, da Vinci X Surgical System
U.S. FDA6 Feb 2020FDA 510(k) clearance K192367: Ion Endoluminal System
U.S. FDA26 Nov 2019FDA 510(k) clearance K191280: E-100 Electrosurgical Generator, SynchroSeal
U.S. FDA14 Nov 2019FDA 510(k) clearance K191736: da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
U.S. FDA26 Jul 2019FDA 510(k) clearance K190999: SureForm 45 Curved Tip, SureForm 45 Gray Reload
U.S. FDA12 Jul 2019FDA 510(k) clearance K182371: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
U.S. FDA14 Mar 2019FDA 510(k) clearance K182188: Ion Endoluminal System ; Flexision Biopsy Needle
U.S. FDA14 Feb 2019FDA 510(k) clearance K183224: SureForm 45, SureForm 45 Reloads
U.S. FDA18 Jan 2019FDA 510(k) clearance K183107: Intuitive Surgical Vessel Sealer Extend
U.S. FDA11 Dec 2018FDA 510(k) clearance K182140: da Vinci Xi Surgical System, da Vinci X Surgical System
U.S. FDA24 Oct 2018FDA 510(k) clearance K180351: EndoWrist Mercury Bipolar Grasper
U.S. FDA7 Aug 2018FDA 510(k) clearance K173585: da Vinci Xi Surgical System, da Vinci X Surgical System
U.S. FDA19 Jul 2018FDA 510(k) clearance K173721: SureForm 60 and SureForm 60 Reloads
U.S. FDA5 Jul 2018FDA 510(k) clearance K173906: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
U.S. FDA31 May 2018FDA 510(k) clearance K173415: EndoWrist 5mm Thoracic Grasper
U.S. FDA31 May 2018FDA 510(k) clearance K173337: Intuitive Surgical EndoWrist Vessel Sealer Extend
U.S. FDA26 Apr 2018FDA 510(k) clearance K173842: da Vinci Xi Surgical System, da Vinci X Surgical System
U.S. FDA23 Apr 2018FDA 510(k) clearance K180033: 8mm Monopolar Curved Scissors
U.S. FDA6 Apr 2018FDA 510(k) clearance K172643: da Vinci Xi Surgical System; da Vinci X Surgical System
U.S. FDA31 Jan 2018FDA 510(k) clearance K170879: IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
U.S. FDA21 Sept 2017FDA 510(k) clearance K170641: da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
U.S. FDA21 Sept 2017FDA 510(k) clearance K171632: da Vinci Xi Surgical System
U.S. FDA19 Sept 2017FDA 510(k) clearance K170875: da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
U.S. FDA12 Sept 2017FDA 510(k) clearance K170645: da Vinci Xi EndoWrist Instruments and Accessories
U.S. FDA11 Sept 2017FDA 510(k) clearance K170644: da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
U.S. FDA11 Sept 2017FDA 510(k) clearance K171699: da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
U.S. FDA28 Jul 2017FDA 510(k) clearance K171426: da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
U.S. FDA13 Jun 2017FDA 510(k) clearance K170713: da Vinci Xi Surgical System
U.S. FDA13 Jun 2017FDA 510(k) clearance K171388: EndoWrist Stapler 45 System and Stapler 45 Reloads
U.S. FDA31 May 2017FDA 510(k) clearance K171294: da Vinci X Surgical System
U.S. FDA26 May 2017FDA 510(k) clearance K170865: EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
U.S. FDA21 Apr 2017FDA 510(k) clearance K170508: EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
U.S. FDA10 Mar 2017FDA 510(k) clearance K162973: EndoWrist Suction Irrigator
U.S. FDA6 Feb 2017FDA 510(k) clearance K161178: da Vinci Xi Surgical System
U.S. FDA19 Jan 2017FDA 510(k) clearance K162411: da Vinci Xi 12 8 mm Reducer
U.S. FDA21 Sept 2016FDA 510(k) clearance K153276: da Vinci Xi Surgical System
U.S. FDA7 Aug 2016FDA 510(k) clearance K161271: da Vinci Xi Surgical System
U.S. FDA11 Jul 2016FDA 510(k) clearance K152892: da Vinci Xi Surgical System
U.S. FDA29 Apr 2016FDA 510(k) clearance K152578: da Vinci Surgical System, Model IS4000
U.S. FDA30 Mar 2016FDA 510(k) clearance K152448: da Vinci Single-Site Instrument and Accessories
U.S. FDA9 Mar 2016FDA 510(k) clearance K152421: IS4000 Stapler 30 Instrument and Stapler 30 Reloads
U.S. FDA4 Mar 2016FDA 510(k) clearance K151794: da Vinci Xi Surgical System
U.S. FDA15 Jan 2016FDA 510(k) clearance K150284: IS4000 da Vinci EndoWrist Instruments
U.S. FDA15 May 2015FDA 510(k) clearance K150837: IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
U.S. FDA29 Apr 2015FDA 510(k) clearance K143132: IS4000 8mm Harmonic ACE Curved Shears
U.S. FDA2 Apr 2015FDA 510(k) clearance K142683: 12 mm Endoscopes and Accessories
U.S. FDA10 Dec 2014FDA 510(k) clearance K143217: 12 mm & Stapler Bladeless Obturators
U.S. FDA3 Dec 2014FDA 510(k) clearance K141075: SINGLE-SITE WRISTED NEEDLE DRIVER
U.S. FDA26 Sept 2014FDA 510(k) clearance K123329: DA VINVI SURGICAL SYSTEM
U.S. FDA17 Sept 2014FDA 510(k) clearance K141077: DA VINCI FIREFLY IMAGING SYSTEM
U.S. FDA12 Aug 2014FDA 510(k) clearance K140553: ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
U.S. FDA25 Jul 2014FDA 510(k) clearance K140189: ENDOWRIST VESSEL SEALER
U.S. FDA5 Jun 2014FDA 510(k) clearance K131962: DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
U.S. FDA17 Apr 2014FDA 510(k) clearance K131861: DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
U.S. FDA28 Mar 2014FDA 510(k) clearance K130266: ENDOWRIST ONE VESSEL SEALER
U.S. FDA29 Aug 2013FDA 510(k) clearance K122532: DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
U.S. FDA30 Jul 2013FDA 510(k) clearance K130726: DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
U.S. FDA7 Jun 2013FDA 510(k) clearance K123840: CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
U.S. FDA14 Feb 2013FDA 510(k) clearance K123463: INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
U.S. FDA3 Dec 2012FDA 510(k) clearance K121921: INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
U.S. FDA25 Oct 2012FDA 510(k) clearance K113706: ENDOWRIST STAPLER SYSTEM
U.S. FDA17 Oct 2012FDA 510(k) clearance K120215: SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
U.S. FDA30 Apr 2012FDA 510(k) clearance K110639: ENDOWRIST ONE VESSEL SEALER
U.S. FDA28 Dec 2011FDA 510(k) clearance K112208: INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
U.S. FDA8 Dec 2011FDA 510(k) clearance K112263: MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
U.S. FDA7 Oct 2011FDA 510(k) clearance K112584: 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
U.S. FDA29 Sept 2011FDA 510(k) clearance K110451: ENDOWRIST ONE SUCTION/IRRIGATOR
U.S. FDA26 Aug 2011FDA 510(k) clearance K101581: INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
U.S. FDA8 Apr 2011FDA 510(k) clearance K101743: 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
U.S. FDA4 Feb 2011FDA 510(k) clearance K093217: 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
U.S. FDA21 Jan 2010FDA 510(k) clearance K090993: INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
U.S. FDA16 Dec 2009FDA 510(k) clearance K082497: INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
U.S. FDA7 May 2009FDA 510(k) clearance K081137: INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
U.S. FDA18 Feb 2009FDA 510(k) clearance K081207: INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
U.S. FDA19 Dec 2008FDA 510(k) clearance K080291: INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
U.S. FDA19 Mar 2008FDA 510(k) clearance K070947: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER
U.S. FDA14 Feb 2008FDA 510(k) clearance K072627: INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER
U.S. FDA7 Feb 2008FDA 510(k) clearance K063220: DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
U.S. FDA1 Dec 2006FDA 510(k) clearance K061260: INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
U.S. FDA18 May 2006FDA 510(k) clearance K060391: INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
U.S. FDA10 Apr 2006FDA 510(k) clearance K050802: MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
U.S. FDA29 Jun 2005FDA 510(k) clearance K050369: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
U.S. FDA29 Apr 2005FDA 510(k) clearance K043288: MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
U.S. FDA3 Mar 2005FDA 510(k) clearance K050005: INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180
U.S. FDA25 Jan 2005FDA 510(k) clearance K043153: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
U.S. FDA15 Dec 2004FDA 510(k) clearance K042855: INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
U.S. FDA12 Nov 2004FDA 510(k) clearance K040237: INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS
U.S. FDA7 Jul 2004FDA 510(k) clearance K040948: INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170
U.S. FDA5 May 2004FDA 510(k) clearance K022574: INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200
U.S. FDA12 Nov 2002FDA 510(k) clearance K021036: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
U.S. FDA26 Jun 2002FDA 510(k) clearance K012833: INTUITIVE SURGICAL BIPOLAR FORCEPS
U.S. FDA16 Nov 2001FDA 510(k) clearance K011281: INTUITIVE SURGICAL ULTRASONIC SHEARS
U.S. FDA24 Jul 2001FDA 510(k) clearance K011002: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
U.S. FDA30 May 2001FDA 510(k) clearance K002489: INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
U.S. FDA2 Mar 2001FDA 510(k) clearance K990144: INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
U.S. FDA11 Jul 2000
Intuitive Surgical
1 machine on robomap





