Data / Medical devices / United States / Intuitive Surgical, Inc.
Intuitive Surgical, Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 1 510(k) clearance
Intuitive Surgical, Inc. is registered with the FDA (registration 3013942591) in Sunnyvale, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013942591
- Address
- 1090 Kifer Road, Sunnyvale, CA, United States, 94086
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer
- First device listed
- August 15, 2023
- Registered through
- 2027
- Brand names listed
- 8 mm SureForm 30 System, EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 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 |
Compare with other makers
- All makers of System, Surgical, Computer Controlled Instrument
- All makers of Staple, Implantable
- All makers of Stapler, Surgical
Updated March 16, 2023. 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.