510(k) K232415

Nalu Neurostimulation System for Peripheral Nerve Stimulation by Boston Scientific Neuromodulation — Product Code GZF

K232415 is an FDA 510(k) premarket notification submitted by Boston Scientific Neuromodulation for the device "Nalu Neurostimulation System for Peripheral Nerve Stimulation". The FDA issued a decision of Substantially Equivalent on August 21, 2024. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870. Boston Scientific Neuromodulation has at least 8 other 510(k) clearances on record.