Data / Medical devices / United States / Intuitive Surgical, Inc.
Intuitive Surgical, Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 19 510(k) clearances
Intuitive Surgical, Inc. is registered with the FDA (registration 3018126215) in Sunnyvale, CA, United States. It lists 6 device types. The FDA files 19 510(k) clearances under its listings, the newest dated July 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3018126215
- Address
- 1050 Kifer Road, Sunnyvale, CA, United States, 94086
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- April 3, 2014
- Registered through
- 2027
- Brand names listed
- 8 mm SureForm 30 System, 8mm Atrial Retractor Short Right, Xi, 8mm Black Diamond Micro Forceps, Xi, 8mm Blunt Obturator Long, Xi, 8mm Blunt Obturator, Xi, 8mm Cadiere Forceps, 8mm Cannula Long, Xi, 8mm Cannula Standard, Xi and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Manufacturer | accessdata.fda.gov |
| Stapler, Surgical | GAG | 2 | Manufacturer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument | NAY | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 14, 2026 | K261249 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 11, 2026 | K253986 | da Vinci Force Feedback Instruments | NAY | 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 |
| June 13, 2025 | K250674 | Vessel Sealer Curved (480522) | 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 |
| 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 5, 2024 | K241635 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| July 3, 2024 | K241284 | da Vinci Surgical System (IS5000) | NAY | 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 |
| 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 |
| August 15, 2022 | K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | 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 |
| November 12, 2020 | K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories | NAY | Unknown | 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 |
| August 7, 2018 | K180351 | EndoWrist Mercury Bipolar Grasper | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 15, 2015 | K150284 | IS4000 da Vinci EndoWrist Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 29, 2015 | K150837 | IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 28, 2014 | K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Surgical, Computer Controlled Instrument
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Insufflator, Laparoscopic
- All makers of Staple, Implantable
- All makers of Stapler, Surgical
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated July 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.