Chrysalis Intelligence · Sponsors · Sonex Health

Sonex Health

Eagan, MN, US · 1 510(k) clearances · 1 recalls

Total clearances
1
2025-09-29 → 2025-09-29
Last 12 months
1
Product codes
1
Most recent
2025-09-29
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRX Arthroscope Class II Orthopedic 1 2025-09-29
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2022-06-29
DateSeverityStatusRecall # ProductCodeReason
2022-06-29 Class II Terminated Z-1387-2022 SX-One MicroKnife Potential of dull blade
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2025-09-29 K252594 UltraGuideCTR® image guided soft tissue release system HRX Class II Orthopedic