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 3014683069) 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. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014683069
- Address
- 4473 Willow Road 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 19, 2025 | 96340 | Class I | Ongoing | CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior. | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and | accessdata.fda.gov |
Compare with other makers
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
Updated March 21, 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.