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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K252594
Device Name UltraGuideCTR® image guided soft tissue release system
Applicant
Sonex Health
950 Blue Gentian Rd.
Suite 200
Eagan,  MN  55121
Applicant Contact Sara Petrie
Correspondent
Sonex Health
950 Blue Gentian Rd.
Suite 200
Eagan,  MN  55121
Correspondent Contact Sara Petrie
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/15/2025
Decision Date 09/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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