510(k) Report

Devices descending from K973442

18 later devices reach Teca Disposable Monopolar Needle Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl20092—
+1K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc.200114—
+2K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S.20101—
+2K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc.200213—
+3K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—
+3K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation200612—
+4K211801SPRINT PNS SystemSpr Therapeutics, Inc.20211—
+4K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC20169—
+4K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation200811—
+5K243782StimTrial Neuromodulation SystemBioventus, LLC20250—
+5K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.20230—
+5K212859First ReliefDyansys, Inc.20210—
+5K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC20177—
+5K090866Neurocalm Model 1 and 2Neuromed Devices, Inc.20090—
+6K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…Spr Therapeutics, Inc.20186—
+7K202660SPRINT PNS SystemSpr Therapeutics, Inc.20215—
+8K213188Primary ReliefDyansys, Inc.20221—
+9K221425Primary ReliefDyansys, Inc.20220—