510(k) Report

Devices descending from K112034

5 later devices reach Teca Elite Disposable Concentric Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…Natus Manufacturing Limited20150—
+1K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe201332
+2K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe20240—
+2K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.20160—
+2K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—