510(k) Report

Devices descending from K183579

6 later devices reach Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243782StimTrial Neuromodulation SystemBioventus, LLC20250—
+1K243678TalisMann Neuromodulation SystemBioventus, LLC20250—
+1K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation20240—
+1K202781Neuspera Neurostimulation System (NNS)Neuspera Medical, Inc.20211—
+1K191435IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4…Nalu Medical, Inc.20190—
+2K221303Neuspera Nuity SystemNeuspera Medical, Inc.20230—