Data / Medical devices / Mexico / Intuitive Surgical, S. de R.L. de C.V.
Intuitive Surgical, S. de R.L. de C.V.: FDA-registered device maker in Mexicali Baja California, Mexico, 2 510(k) clearances
Intuitive Surgical, S. de R.L. de C.V. is registered with the FDA (registration 3007084728) in Mexicali Baja California, Mexico. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 3, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3007084728
- Address
- Circuito Internacional Sur #21-A Parque Industrial Nelson, Carretera a San Luis R.C., Km 14, Mexicali Baja California, Mexico, 21397
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- September 9, 2021
- Registered through
- 2027
- Brand names listed
- Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000), Ion Fully Articulating Catheter, Ion Peripheral Vision Probe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| April 3, 2024 | K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (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 |
Compare with other makers
Updated April 3, 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.