510(k) Report

Devices descending from K021989

23 later devices reach Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102258Cusa NXT Extended Length TipIntegra Radionics, Inc.20112—
+1K101561TX1 Tissue Removal SystemAmerican Optisurgical, Inc.201032
+1K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc.2008164
+1K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc.200717—
+1K042277Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd.200417—
+2K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2016112
+2K123640TX1 Tissue Removal SystemTenex Health201321
+2K111741Integra (TM) Cusa NXT (TM) Bone TipsIntegra Burlington Ma, Inc. (Formerly Integra Radi20111—
+2K090864Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator SystemIntegra Radionics, Inc.20090—
+3K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20181042
+3K153299Tenex Health TX SystemTenex Health, Inc.20161—
+3K113570Integra Cusa NXT Inferior Foward Bone TipIntegra Burlington Ma, Inc.20120—
+4K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20250—
+4K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20240—
+4K212049Oclet TDS 1000Tendonova Corporation20220—
+4K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20205—
+4K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20191—
+5K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20230—
+5K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20220—
+5K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.20222—
+5K221763CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20220—
+6K231117neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company20231—
+7K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC20260—