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Intuitive Surgical, Inc.

179 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Intuitive Endoluminal Gastrointestinal System (IG1000) (K253702)Intuitive Surgical, Inc.2026-08-07
da Vinci Surgical System, Model IS5000 (K261824)Intuitive Surgical, Inc.2026-07-31
Universal Seal (5-12 mm) (K261249)Intuitive Surgical, Inc.2026-07-14
da Vinci Force Feedback Instruments (K253986)Intuitive Surgical, Inc.2026-03-11
Universal Seal (5-12 mm) (K253978)Intuitive Surgical, Inc.2026-02-24
da Vinci Surgical System (IS5000) (K251739)Intuitive Surgical, Inc.2026-01-16
da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (K253556)Intuitive Surgical, Inc.2026-01-16
IRISeg (K251763)Intuitive Surgical, Inc.2025-12-16
da Vinci SP Surgical System (SP1098) (K252675)Intuitive Surgical, Inc.2025-12-15
da Vinci SP Surgical System (SP1098) (K252069)Intuitive Surgical, Inc.2025-12-02
da Vinci SP Surgical System (SP1098) (K251426)Intuitive Surgical, Inc.2025-10-03
Ion Endoluminal System (IF1000) (K252045)Intuitive Surgical, Inc.2025-09-23
da Vinci SP Surgical System (SP1098) (K251817)Intuitive Surgical, Inc.2025-09-10
da Vinci Surgical System (IS5000) (K251227)Intuitive Surgical, Inc.2025-09-08
Ion Endoluminal System (IF1000) (K252528)Intuitive Surgical, Inc.2025-09-05
da Vinci SP Surgical System (SP1098) (K251324)Intuitive Surgical, Inc.2025-08-29
da Vinci SP Firefly Imaging System (K252350)Intuitive Surgical, Inc.2025-08-28
da Vinci Surgical System, IS5000 (K250442)Intuitive Surgical, Inc.2025-07-29
Da Vinci Surgical System (IS5000) (K251213)Intuitive Surgical, Inc.2025-07-23
da Vinci Surgical System (IS5000) (K251202)Intuitive Surgical, Inc.2025-07-16
8 mm Assist Cannula; 12 mm Assist Cannula (K251490)Intuitive Surgical, Inc.2025-07-02
Vessel Sealer Curved (480522) (K250674)Intuitive Surgical, Inc.2025-06-13
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) (K240852)Intuitive Surgical, Inc.2025-06-11
SP Endoscope, 0° (430600) (K250786)Intuitive Surgical, Inc.2025-05-13
da Vinci SP Surgical System (SP1098) (K243714)Intuitive Surgical, Inc.2025-04-24
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (K242427)Intuitive Surgical, Inc.2025-04-01
da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (K243596)Intuitive Surgical, Inc.2025-03-10
da Vinci SP Advanced Access Port Kit (432701) (K243582)Intuitive Surgical, Inc.2025-02-28
da Vinci Surgical System (IS5000) (K243641)Intuitive Surgical, Inc.2024-12-16
IRISeg (K242461)Intuitive Surgical, Inc.2024-12-10
da Vinci SP Surgical System (SP1098) (K242318)Intuitive Surgical, Inc.2024-11-26
da Vinci SP Instruments (SP1098) (K241814)Intuitive Surgical, Inc.2024-11-18
Ion Endoluminal System (IF 1000) (K242070)Intuitive Surgical, Inc.2024-09-24
8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads (K241638)Intuitive Surgical, Inc.2024-09-10
Universal Seal (5-12 mm) (K241360)Intuitive Surgical, Inc.2024-08-05
da Vinci SP Surgical System (SP1098) (K240502)Intuitive Surgical, Inc.2024-07-08
da Vinci Surgical System (IS5000) (K241284)Intuitive Surgical, Inc.2024-07-03
da Vinci SP Surgical System (SP1098) (K232773)Intuitive Surgical, Inc.2024-06-04
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) (K240135)Intuitive Surgical, Inc.2024-04-03
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (K232610)Intuitive Surgical, Inc.2024-03-14
Ion Endoluminal System (IF1000) (K232984)Intuitive Surgical, Inc.2023-12-18
da Vinci SP Surgical System (K231798)Intuitive Surgical, Inc.2023-11-08
Universal Seal (5-12 mm) (K231358)Intuitive Surgical, Inc.2023-07-05
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K231224)Intuitive Surgical, Inc.2023-05-12
Da Vinci SP Surgical System (SP1098) (K230033)Intuitive Surgical, Inc.2023-04-05
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System (K222839)Intuitive Surgical, Inc.2023-03-16
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) (K223080)Intuitive Surgical, Inc.2022-11-22
da Vinci Firefly Imaging System (K222827)Intuitive Surgical, Inc.2022-10-20
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments (K214095)Intuitive Surgical, Inc.2022-08-15
Ion Endoluminal System (IF1000) (K220299)Intuitive Surgical, Inc.2022-06-16
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (K213710)Intuitive Surgical, Inc.2022-02-17
8mm Monopolar Curved Scissors (K220023)Intuitive Surgical, Inc.2022-01-31
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads (K211997)Intuitive Surgical, Inc.2021-12-10
da Vinci SP Firefly Imaging System (K212101)Intuitive Surgical, Inc.2021-11-23
Da Vinci SP Surgical System (K212747)Intuitive Surgical, Inc.2021-09-29
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) (K212048)Intuitive Surgical, Inc.2021-08-26
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K211784)Intuitive Surgical, Inc.2021-08-06
da Vinci SP Surgical System (SP1098) (K211316)Intuitive Surgical, Inc.2021-07-23
da Vinci SP Surgical System (SP1098) (K211595)Intuitive Surgical, Inc.2021-06-23
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (K210918)Intuitive Surgical, Inc.2021-04-26
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments (K203632)Intuitive Surgical, Inc.2021-02-10
Da Vinci SP Surgical System (K202968)Intuitive Surgical, Inc.2020-12-22
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K202834)Intuitive Surgical, Inc.2020-12-10
Ion Endoluminal System (K202370)Intuitive Surgical, Inc.2020-11-16
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (K202571)Intuitive Surgical, Inc.2020-11-12
da Vinci SP Surgical System (K192717)Intuitive Surgical, Inc.2020-09-28
Ion Endoluminal System (K201146)Intuitive Surgical, Inc.2020-06-26
da Vinci X and Xi Surgical System (K183086)Intuitive Surgical, Inc.2020-03-31
Ion Endoluminal System (K192367)Intuitive Surgical, Inc.2019-11-26
E-100 Electrosurgical Generator, SynchroSeal (K191280)Intuitive Surgical, Inc.2019-11-14
SureForm 45 Curved Tip, SureForm 45 Gray Reload (K190999)Intuitive Surgical, Inc.2019-07-12
da Vinci Handheld Camera (K191043)Intuitive Surgical, Inc.2019-06-06
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K182371)Intuitive Surgical, Inc.2019-03-14
Endoscope Sterilization Tray (K183139)Intuitive Surgical, Inc.2019-02-01
Intuitive Surgical Vessel Sealer Extend (K183107)Intuitive Surgical, Inc.2018-12-11
da Vinci Xi Surgical System, da Vinci X Surgical System (K182140)Intuitive Surgical, Inc.2018-10-24
Endoscope Sterilization Tray (K180964)Intuitive Surgical, Inc.2018-09-28
EndoWrist Mercury Bipolar Grasper (K180351)Intuitive Surgical, Inc.2018-08-07
Universal Cannula Seal (5-12 mm) (K181395)Intuitive Surgical, Inc.2018-07-27
da Vinci Xi Surgical System, da Vinci X Surgical System (K173585)Intuitive Surgical, Inc.2018-07-19
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K173906)Intuitive Surgical, Inc.2018-05-31
EndoWrist 5mm Thoracic Grasper (K173415)Intuitive Surgical, Inc.2018-05-31
Intuitive Surgical EndoWrist Vessel Sealer Extend (K173337)Intuitive Surgical, Inc.2018-04-26
da Vinci Xi Surgical System, da Vinci X Surgical System (K173842)Intuitive Surgical, Inc.2018-04-23
8mm Monopolar Curved Scissors (K180033)Intuitive Surgical, Inc.2018-04-06
da Vinci Xi Surgical System; da Vinci X Surgical System (K172643)Intuitive Surgical, Inc.2018-01-31
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories (K170879)Intuitive Surgical, Inc.2017-09-21
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes (K170641)Intuitive Surgical, Inc.2017-09-21
da Vinci Xi Surgical System (K171632)Intuitive Surgical, Inc.2017-09-19
Endoscope Sterilization Tray (K170640)Intuitive Surgical, Inc.2017-09-17
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories (K170875)Intuitive Surgical, Inc.2017-09-12
da Vinci Xi EndoWrist Instruments and Accessories (K170645)Intuitive Surgical, Inc.2017-09-11
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) (K170644)Intuitive Surgical, Inc.2017-09-11
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System (K171699)Intuitive Surgical, Inc.2017-07-28
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree (K171426)Intuitive Surgical, Inc.2017-06-13
da Vinci Xi Surgical System (K170713)Intuitive Surgical, Inc.2017-06-13
EndoWrist Stapler 45 System and Stapler 45 Reloads (K171388)Intuitive Surgical, Inc.2017-05-31
da Vinci X Surgical System (K171294)Intuitive Surgical, Inc.2017-05-26
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories (K170865)Intuitive Surgical, Inc.2017-04-21
EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads (K170508)Intuitive Surgical, Inc.2017-03-10
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