510(k) Report

Devices descending from K943873

2 later devices reach Orthomet Anatomically Guided Carpal Tunnel Release SY through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192873SX-One MicroKnifeSonex Health, Inc.201911
+2K252594UltraGuideCTR® image guided soft tissue release systemSonex Health20250—