510(k) Report

Devices descending from K071185

5 later devices reach Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093825Ambu Neuroline Disposable Inoject Needle ElectrodeAmbu A/S20100—
+1K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl20092—
+1K091056Rhythmlink Disposable Monopolar Emg Needle, Model TFDN26032252RRhythmlink International, LLC20090—
+2K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S.20101—
+3K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—