510(k) Report

Devices descending from K161154

9 later devices reach Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243782StimTrial Neuromodulation SystemBioventus, LLC20250—
+1K212859First ReliefDyansys, Inc.20210—
+1K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC20177—
+2K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…Spr Therapeutics, Inc.20186—
+3K202660SPRINT PNS SystemSpr Therapeutics, Inc.20215—
+4K213188Primary ReliefDyansys, Inc.20221—
+4K211801SPRINT PNS SystemSpr Therapeutics, Inc.20211—
+5K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.20230—
+5K221425Primary ReliefDyansys, Inc.20220—