510(k) Report

Devices descending from K982142

11 later devices reach Mountable Endoscopic Knife through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080133Mountable Endoscopic BladeA.M. Surgical, Inc.20089—
+1K072684Mondeal Endoscopic Tissue Recession and Release SystemMondeal North America, Inc.20080—
+2K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210—
+2K200559CarpXPavmed, Inc.20200—
+2K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186—
+2K102219Socorro Smi Tunnel Release DeviceSocorro Medical, Inc.20100—
+3K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.20250—
+3K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments202321
+3K222490HBL Blade AssemblyHand Biomechanics Lab, Inc.20221—
+4K252594UltraGuideCTR® image guided soft tissue release systemSonex Health20250—
+4K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC20240—