510(k) Report

Devices descending from K171366

9 later devices reach Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix20240—
+1K200848Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitMicron Medical Corporation20200—
+1K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation…Boston Scientific Neuromodulation201961
+2K243782StimTrial Neuromodulation SystemBioventus, LLC20250—
+2K243678TalisMann Neuromodulation SystemBioventus, LLC20250—
+2K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation20240—
+2K202781Neuspera Neurostimulation System (NNS)Neuspera Medical, Inc.20211—
+2K191435IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4…Nalu Medical, Inc.20190—
+3K221303Neuspera Nuity SystemNeuspera Medical, Inc.20230—