UltraGuideCTR® image guided soft tissue release system— 510(k) K252594

Substantially Equivalent

Sonex Health

FDA 510(k) clearance K252594 for UltraGuideCTR® image guided soft tissue release system, Substantially Equivalent on 2025-09-29. Applicant: Sonex Health.

Clearance details

Applicant: Sonex Health
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2025-08-15
Decision date: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eagan, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.