Data / Medical devices / United States / Intuitive Surgical, Inc.
Intuitive Surgical, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 4 510(k) clearances
Intuitive Surgical, Inc. is registered with the FDA (registration 3038182369) in Santa Clara, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated September 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3038182369
- Address
- 3859 Kifer Road --, Santa Clara, CA, United States, 95051
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer
- First device listed
- February 27, 2019
- Registered through
- 2027
- Brand names listed
- Bath Probe, Catheter Continuity Cable, Catheter Continuity Stand, Catheter Guide, Controller, Flexision Biopsy Needle 19G, Flexision Biopsy Needle 21G, Flexision Biopsy Needle 23G and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 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 |
|---|---|---|---|---|---|---|
| September 23, 2025 | K252045 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | 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 |
| November 26, 2019 | K192367 | Ion Endoluminal System | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 14, 2019 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | EOQ | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
Compare with other makers
Updated September 23, 2025. 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.