Data / Medical devices / United States / Intuitive Surgical, Inc.
Intuitive Surgical, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 190 510(k) clearances
Intuitive Surgical, Inc. is registered with the FDA (registration 3015612252) in Santa Clara, CA, United States. It lists 29 device types. The FDA files 190 510(k) clearances under its listings, the newest dated October 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015612252
- Address
- 3410 Central Expressway --, Santa Clara, CA, United States, 95051
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Complaint file establishment, Manufacturer for export
- First device listed
- January 6, 1998
- Registered through
- 2027
- Brand names listed
- 10-12mm+Stapler Cannula Seal, 12 Mm & Stapler Bladeless Obturator, 12 mm Assist Cannula, 12 mm Blunt Obturator, da Vinci S, Si, 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si, 12 mm Endoscope Cannula Mount, Balloon Port, 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci, 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 190.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 14, 2026 | K262455 | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 8, 2026 | K261823 | da Vinci Surgical System, Model IS5000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 7, 2026 | K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | FDS | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 31, 2026 | K261824 | da Vinci Surgical System, Model IS5000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 14, 2026 | K261249 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 22, 2026 | K260695 | da Vinci Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| March 11, 2026 | K253986 | da Vinci Force Feedback Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 24, 2026 | K253978 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 16, 2026 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 16, 2026 | K251739 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 16, 2025 | K251763 | IRISeg | QIH | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 15, 2025 | K252675 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 2, 2025 | K252069 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 3, 2025 | K251426 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 23, 2025 | K252045 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 10, 2025 | K251817 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 8, 2025 | K251227 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 5, 2025 | K252528 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 29, 2025 | K251324 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 28, 2025 | K252350 | da Vinci SP Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 29, 2025 | K250442 | da Vinci Surgical System, IS5000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 23, 2025 | K251213 | Da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 16, 2025 | K251202 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 2, 2025 | K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 13, 2025 | K250674 | Vessel Sealer Curved (480522) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 11, 2025 | K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 13, 2025 | K250786 | SP Endoscope, 0° (430600) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 24, 2025 | K243714 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 1, 2025 | K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 10, 2025 | K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | GAG | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 28, 2025 | K243582 | da Vinci SP Advanced Access Port Kit (432701) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 16, 2024 | K243641 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 10, 2024 | K242461 | IRISeg | QIH | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 26, 2024 | K242318 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 18, 2024 | K241814 | da Vinci SP Instruments (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 24, 2024 | K242070 | Ion Endoluminal System (IF 1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 10, 2024 | K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 28, 2024 | K241913 | da Vinci Handheld Camera | GCJ | Substantially Equivalent | Intuitive Surgical Operations, Inc. | accessdata.fda.gov |
| August 5, 2024 | K241635 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| August 5, 2024 | K241360 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 2, 2024 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| July 8, 2024 | K240502 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 3, 2024 | K241284 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 4, 2024 | K232773 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 24, 2024 | K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| April 3, 2024 | K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 14, 2024 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 18, 2023 | K232984 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 8, 2023 | K231798 | da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 5, 2023 | K231358 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 21, 2023 | K231212 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| May 12, 2023 | K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 5, 2023 | K230033 | Da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 16, 2023 | K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 23, 2023 | K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | GCJ | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| November 28, 2022 | K223039 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| November 22, 2022 | K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 20, 2022 | K222827 | da Vinci Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 15, 2022 | K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 16, 2022 | K220299 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 17, 2022 | K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 31, 2022 | K220023 | 8mm Monopolar Curved Scissors | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 10, 2021 | K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 23, 2021 | K212101 | da Vinci SP Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 29, 2021 | K212747 | Da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 26, 2021 | K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 6, 2021 | K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 23, 2021 | K211316 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 23, 2021 | K211595 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 26, 2021 | K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 10, 2021 | K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 22, 2020 | K202968 | Da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 10, 2020 | K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 16, 2020 | K202370 | Ion Endoluminal System | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 12, 2020 | K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 28, 2020 | K192717 | da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 26, 2020 | K201146 | Ion Endoluminal System | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 29, 2020 | K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| March 31, 2020 | K183086 | da Vinci X and Xi Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 6, 2020 | K191529 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| November 26, 2019 | K192367 | Ion Endoluminal System | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 14, 2019 | K191280 | E-100 Electrosurgical Generator, SynchroSeal | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 26, 2019 | K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| July 12, 2019 | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 6, 2019 | K191043 | da Vinci Handheld Camera | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 14, 2019 | K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 22, 2019 | K182643 | IRIS 1.0 System | LLZ | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| February 14, 2019 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | EOQ | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| February 1, 2019 | K183139 | Endoscope Sterilization Tray | KCT | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 18, 2019 | K183224 | SureForm 45, SureForm 45 Reloads | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| December 11, 2018 | K183107 | Intuitive Surgical Vessel Sealer Extend | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 24, 2018 | K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 28, 2018 | K180964 | Endoscope Sterilization Tray | KCT | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 7, 2018 | K180351 | EndoWrist Mercury Bipolar Grasper | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 27, 2018 | K181395 | Universal Cannula Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 19, 2018 | K173585 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 5, 2018 | K173721 | SureForm 60 and SureForm 60 Reloads | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| May 31, 2018 | K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 31, 2018 | K173415 | EndoWrist 5mm Thoracic Grasper | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 26, 2018 | K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
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Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.