SONEX HEALTH LLC

FDA Regulatory Profile

SONEX HEALTH LLC appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1387-2022, Class II) was initiated on June 29, 2022. Its most recent 510(k) clearance was granted on September 29, 2025.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1387-2022Class IISX-One MicroKnifeJune 29, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K252594UltraGuideCTR® image guided soft tissue release systemSeptember 29, 2025
K192873SX-One MicroKnifeDecember 20, 2019