Data / Medical devices / United States / Aulea Medical, Inc.
Aulea Medical, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 2 510(k) clearances
Aulea Medical, Inc. is registered with the FDA (registration 3028977843) in Pleasanton, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3028977843
- Address
- 5627 Stoneridge Dr Ste 312, Pleasanton, CA, United States, 94588
- Owner or operator
- Aulea Medical, Inc. (10088655)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- September 18, 2023
- Registered through
- 2026
- Brand names listed
- Veloxion
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Evacuator, Gastro-Urology | KQT | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Resectoscope | FJL | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | 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 24, 2023 | K230205 | Veloxion System | FJL | Substantially Equivalent | Corinth Medtech, Inc. | accessdata.fda.gov |
| June 13, 2019 | K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | FJL | Substantially Equivalent | Corinth Medtech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Resectoscope
- All makers of Evacuator, Gastro-Urology
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated February 24, 2023. 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.