Data / Medical devices / United States / Calyxo, Inc.
Calyxo, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 1 510(k) clearance
Calyxo, Inc. is registered with the FDA (registration 3032959393) in Pleasanton, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032959393
- Address
- 4430 Rosewood Dr. Suite 100, Pleasanton, CA, United States, 94588
- Owner or operator
- Calyxo, Inc. (10058093)
- Roles
- Manufacturer
- First device listed
- February 15, 2024
- Registered through
- 2026
- Brand names listed
- CVAC Aspiration System (CVAC 2.1, K261447), CVAC Aspiration System and CVAC Image Processor (K233472), CVAC Image Processor (K233472), CVAC Image Processor (SW 1.5, K260013)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 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 |
|---|---|---|---|---|---|---|
| February 2, 2024 | K233472 | CVAC Aspiration System + CVAC Image Processor | FED | Substantially Equivalent | Calyxo, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
Updated February 2, 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.