Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Intuitive Surgical, Inc.

FDA 510(k) & PMA Approved Devices — 107 products

Total Devices107
Categories6
Latest Approval2026-03-11
TypeNumberDevice NameCodeDate
510(k) K253986 da Vinci Force Feedback Instruments NAY 2026-03-11 View
510(k) K253978 Universal Seal (5-12 mm) GCJ 2026-02-24 View
510(k) K253556 da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator NAY 2026-01-16 View
510(k) K251739 da Vinci Surgical System (IS5000) NAY 2026-01-16 View
510(k) K251763 IRISeg QIH 2025-12-16 View
510(k) K252675 da Vinci SP Surgical System (SP1098) NAY 2025-12-15 View
510(k) K252069 da Vinci SP Surgical System (SP1098) NAY 2025-12-02 View
510(k) K251426 da Vinci SP Surgical System (SP1098) NAY 2025-10-03 View
510(k) K252045 Ion Endoluminal System (IF1000) EOQ 2025-09-23 View
510(k) K251817 da Vinci SP Surgical System (SP1098) NAY 2025-09-10 View
510(k) K251227 da Vinci Surgical System (IS5000) NAY 2025-09-08 View
510(k) K252528 Ion Endoluminal System (IF1000) EOQ 2025-09-05 View
510(k) K251324 da Vinci SP Surgical System (SP1098) NAY 2025-08-29 View
510(k) K252350 da Vinci SP Firefly Imaging System NAY 2025-08-28 View
510(k) K250442 da Vinci Surgical System, IS5000 NAY 2025-07-29 View
510(k) K251213 Da Vinci Surgical System (IS5000) NAY 2025-07-23 View
510(k) K251202 da Vinci Surgical System (IS5000) NAY 2025-07-16 View
510(k) K251490 8 mm Assist Cannula; 12 mm Assist Cannula GCJ 2025-07-02 View
510(k) K250674 Vessel Sealer Curved (480522) NAY 2025-06-13 View
510(k) K240852 da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) NAY 2025-06-11 View
510(k) K250786 SP Endoscope, 0° (430600) NAY 2025-05-13 View
510(k) K243714 da Vinci SP Surgical System (SP1098) NAY 2025-04-24 View
510(k) K242427 da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) NAY 2025-04-01 View
510(k) K243596 da Vinci SP SureForm 45 Staplers and Reloads (SP1098) GAG 2025-03-10 View
510(k) K243582 da Vinci SP Advanced Access Port Kit (432701) NAY 2025-02-28 View
510(k) K243641 da Vinci Surgical System (IS5000) NAY 2024-12-16 View
510(k) K242461 IRISeg QIH 2024-12-10 View
510(k) K242318 da Vinci SP Surgical System (SP1098) NAY 2024-11-26 View
510(k) K241814 da Vinci SP Instruments (SP1098) NAY 2024-11-18 View
510(k) K242070 Ion Endoluminal System (IF 1000) EOQ 2024-09-24 View
510(k) K241638 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads NAY 2024-09-10 View
510(k) K241360 Universal Seal (5-12 mm) GCJ 2024-08-05 View
510(k) K240502 da Vinci SP Surgical System (SP1098) NAY 2024-07-08 View
510(k) K241284 da Vinci Surgical System (IS5000) NAY 2024-07-03 View
510(k) K232773 da Vinci SP Surgical System (SP1098) NAY 2024-06-04 View
510(k) K240135 Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) EOQ 2024-04-03 View
510(k) K232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation NAY 2024-03-14 View
510(k) K232984 Ion Endoluminal System (IF1000) EOQ 2023-12-18 View
510(k) K231798 da Vinci SP Surgical System NAY 2023-11-08 View
510(k) K231358 Universal Seal (5-12 mm) GCJ 2023-07-05 View
510(k) K231224 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) NAY 2023-05-12 View
510(k) K230033 Da Vinci SP Surgical System (SP1098) NAY 2023-04-05 View
510(k) K222839 EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System NAY 2023-03-16 View
510(k) K223080 da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) NAY 2022-11-22 View
510(k) K222827 da Vinci Firefly Imaging System NAY 2022-10-20 View
510(k) K214095 da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments NAY 2022-08-15 View
510(k) K220299 Ion Endoluminal System (IF1000) EOQ 2022-06-16 View
510(k) K213710 da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System NAY 2022-02-17 View
510(k) K220023 8mm Monopolar Curved Scissors NAY 2022-01-31 View
510(k) K211997 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads NAY 2021-12-10 View
510(k) K212101 da Vinci SP Firefly Imaging System NAY 2021-11-23 View
510(k) K212747 Da Vinci SP Surgical System NAY 2021-09-29 View
510(k) K212048 Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) EOQ 2021-08-26 View
510(k) K211784 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) NAY 2021-08-06 View
510(k) K211316 da Vinci SP Surgical System (SP1098) NAY 2021-07-23 View
510(k) K211595 da Vinci SP Surgical System (SP1098) NAY 2021-06-23 View
510(k) K210918 da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System NAY 2021-04-26 View
510(k) K203632 da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments NAY 2021-02-10 View
510(k) K202968 Da Vinci SP Surgical System NAY 2020-12-22 View
510(k) K202834 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) NAY 2020-12-10 View
510(k) K202370 Ion Endoluminal System EOQ 2020-11-16 View
510(k) K202571 da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories NAY 2020-11-12 View
510(k) K192717 da Vinci SP Surgical System NAY 2020-09-28 View
510(k) K201146 Ion Endoluminal System EOQ 2020-06-26 View
510(k) K183086 da Vinci X and Xi Surgical System NAY 2020-03-31 View
510(k) K192367 Ion Endoluminal System EOQ 2019-11-26 View
510(k) K191280 E-100 Electrosurgical Generator, SynchroSeal NAY 2019-11-14 View
510(k) K190999 SureForm 45 Curved Tip, SureForm 45 Gray Reload NAY 2019-07-12 View
510(k) K191043 da Vinci Handheld Camera GCJ 2019-06-06 View
510(k) K182371 da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories NAY 2019-03-14 View
510(k) K183139 Endoscope Sterilization Tray KCT 2019-02-01 View
510(k) K183107 Intuitive Surgical Vessel Sealer Extend NAY 2018-12-11 View
510(k) K182140 da Vinci Xi Surgical System, da Vinci X Surgical System NAY 2018-10-24 View
510(k) K180964 Endoscope Sterilization Tray KCT 2018-09-28 View
510(k) K180351 EndoWrist Mercury Bipolar Grasper NAY 2018-08-07 View
510(k) K181395 Universal Cannula Seal (5-12 mm) GCJ 2018-07-27 View
510(k) K173585 da Vinci Xi Surgical System, da Vinci X Surgical System NAY 2018-07-19 View
510(k) K173415 EndoWrist 5mm Thoracic Grasper NAY 2018-05-31 View
510(k) K173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories NAY 2018-05-31 View
510(k) K173337 Intuitive Surgical EndoWrist Vessel Sealer Extend NAY 2018-04-26 View
510(k) K173842 da Vinci Xi Surgical System, da Vinci X Surgical System NAY 2018-04-23 View
510(k) K180033 8mm Monopolar Curved Scissors NAY 2018-04-06 View
510(k) K172643 da Vinci Xi Surgical System; da Vinci X Surgical System NAY 2018-01-31 View
510(k) K170641 da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes NAY 2017-09-21 View
510(k) K170879 IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories NAY 2017-09-21 View
510(k) K171632 da Vinci Xi Surgical System NAY 2017-09-19 View
510(k) K170640 Endoscope Sterilization Tray KCT 2017-09-17 View
510(k) K170875 da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories NAY 2017-09-12 View
510(k) K170645 da Vinci Xi EndoWrist Instruments and Accessories NAY 2017-09-11 View
510(k) K170644 da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) NAY 2017-09-11 View
510(k) K171699 da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System NAY 2017-07-28 View
510(k) K170713 da Vinci Xi Surgical System NAY 2017-06-13 View
510(k) K171426 da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree NAY 2017-06-13 View
510(k) K171388 EndoWrist Stapler 45 System and Stapler 45 Reloads NAY 2017-05-31 View
510(k) K171294 da Vinci X Surgical System NAY 2017-05-26 View
510(k) K170865 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories NAY 2017-04-21 View
510(k) K170508 EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads NAY 2017-03-10 View
510(k) K162973 EndoWrist Suction Irrigator NAY 2017-02-06 View
510(k) K161178 da Vinci Xi Surgical System NAY 2017-01-19 View
510(k) K162411 da Vinci Xi 12 – 8 mm Reducer NAY 2016-09-21 View
510(k) K153276 da Vinci Xi Surgical System NAY 2016-08-07 View
510(k) K161271 da Vinci Xi Surgical System NAY 2016-07-11 View
510(k) K152578 da Vinci Surgical System, Model IS4000 NAY 2016-03-30 View
510(k) K152448 da Vinci Single-Site Instrument and Accessories NAY 2016-03-09 View
510(k) K152421 IS4000 Stapler 30 Instrument and Stapler 30 Reloads NAY 2016-03-04 View
510(k) K151794 da Vinci Xi Surgical System NAY 2016-01-15 View
510(k) K151450 Endoscope Sterilization Tray KCT 2016-01-12 View
↑