510(k) Report

Devices descending from K950314

15 later devices reach Dantec Monopolar Lumen Electrode (13R18 and 13R19) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc.200114—
+2K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc.200213—
+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—