510(k) Report

Devices descending from K181819

6 later devices reach SMARTRELEASE Endoscopic Soft Tissue Release System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.20250—
+1K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments202321
+1K222490HBL Blade AssemblyHand Biomechanics Lab, Inc.20221—
+1K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210—
+2K252594UltraGuideCTR® image guided soft tissue release systemSonex Health20250—
+2K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC20240—