Data / Medical devices / United States / Intuitive Surgical, Inc.
Intuitive Surgical, Inc.: FDA-registered device maker in Phoenix, AZ, United States, 2 510(k) clearances
Intuitive Surgical, Inc. is registered with the FDA (registration 3015241782) in Phoenix, AZ, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 14, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015241782
- Address
- 4550 W Watkins Street Suite 120, Phoenix, AZ, United States, 85043
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer
- First device listed
- December 7, 2009
- Registered through
- 2027
- Brand names listed
- 12 mm Endoscope, 0°, 12 mm Endoscope, 30°, 3DHD Camera Head and Cable, 8mm Endoscope, 0°, Gen5, 8mm Endoscope, 30°, Gen5, 8mm Hex Cannula, Long, 8mm Hex Cannula, Standard, ASSY,PSCART,IS3000,3-ARM 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 |
| Laparoscopy Kit | FDE | 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 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 |
| February 18, 2009 | K081137 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscopy Kit
- All makers of Laparoscope, General & Plastic Surgery
- All makers of System, Surgical, Computer Controlled Instrument
- All makers of Insufflator, Laparoscopic
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated March 14, 2024. 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.