510(k) Report

Devices descending from K080133

9 later devices reach Mountable Endoscopic Blade through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210—
+1K200559CarpXPavmed, Inc.20200—
+1K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186—
+1K102219Socorro Smi Tunnel Release DeviceSocorro Medical, Inc.20100—
+2K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.20250—
+2K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments202321
+2K222490HBL Blade AssemblyHand Biomechanics Lab, Inc.20221—
+3K252594UltraGuideCTR® image guided soft tissue release systemSonex Health20250—
+3K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC20240—