Data / Medical devices / United States / Sureax Medical, Corporation
Sureax Medical, Corporation: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
Sureax Medical, Corporation is registered with the FDA (registration 3024682301) in San Diego, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024682301
- Address
- 11107 Roselle St 237, San Diego, CA, United States, 92121
- Owner or operator
- SureAx Medical, Corporation (10086251)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- August 24, 2023
- Registered through
- 2026
- Brand names listed
- Hook, IMX Needle, LNX Needle, SureAx Guide, SureAx Curve/Guide Convenience Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Repackager or relabeler, Reprocessor, 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 |
|---|---|---|---|---|---|---|
| October 17, 2025 | K250203 | SureAx-Guide | DQX | Substantially Equivalent | Sureax Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Guide, Catheter
- All makers of Guide, Needle, Surgical
- All makers of Needle, Aspiration And Injection, Disposable
Updated October 17, 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.