Data / Medical devices / United States / SONEX HEALTH, Inc
SONEX HEALTH, Inc: FDA-registered device maker in Eagan, MN, United States, 1 510(k) clearance
SONEX HEALTH, Inc is registered with the FDA (registration 3013479847) in Eagan, MN, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013479847
- Address
- 950 Blue Gentian Road Suite 200, Eagan, MN, United States, 55121
- Owner or operator
- Sonex Health, Inc (10053414)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 2, 2016
- Registered through
- 2026
- Brand names listed
- UltraGuideCTR, UltraGuideTFR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 29, 2025 | K252594 | UltraGuideCTR® image guided soft tissue release system | HRX | Substantially Equivalent | Sonex Health | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 29, 2022 | 90520 | Class II | Terminated | SX-One MicroKnife | Potential of dull blade | accessdata.fda.gov |
Compare with other makers
Updated September 29, 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.