510(k) Report

Devices descending from K002992

8 later devices reach Disposable Hypodermic Needle Electrode, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093825Ambu Neuroline Disposable Inoject Needle ElectrodeAmbu A/S20100—
+1K062437Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledTechnomed Europe20076—
+2K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe201332
+2K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S.20101—
+2K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl20092—
+3K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe20240—
+3K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.20160—
+3K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—