510(k) Report

Devices descending from K915741

7 later devices reach Disposable Monoplar Meddle Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990375Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75Medtronic Functional Diagnostics A/S19996—
+2K072276Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd.20085—
+3K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.20230—
+3K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe201332
+4K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe20240—
+4K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.20160—
+4K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—