Data / Medical devices / United States / Intuitive Surgical, Inc.
Intuitive Surgical, Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 6 510(k) clearances
Intuitive Surgical, Inc. is registered with the FDA (registration 2955842) in Sunnyvale, CA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 16, 2026. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2955842
- FEI number
- 3008615487
- Address
- 950 Kifer Road, Sunnyvale, CA, United States, 94086
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- March 15, 2024
- Registered through
- 2027
- Brand names listed
- 8mm Endoscope, 0°, Gen5, 8mm Endoscope, 30°, Gen5, 8mm Hex Cannula, Long, 8mm Hex Cannula, Standard, Blue System Cable, Type B, 7m, CABLE KIT,BLUE FIBERCONNECT,20M, CO2 Tank Gas Accessory, CGA 940, CO2 Tank Gas Accessory, DIN 477 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, Manufacturer for export | 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 | 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 |
|---|---|---|---|---|---|---|
| January 16, 2026 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | 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 |
| 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 |
| November 18, 2024 | K241814 | da Vinci SP Instruments (SP1098) | NAY | Unknown | 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 |
Compare with other makers
- All makers of System, Surgical, Computer Controlled Instrument
- All makers of Staple, Implantable
- All makers of Stapler, Surgical
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Insufflator, Laparoscopic
Updated January 16, 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.