510(k) K233801

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation by Boston Scientific Neuromodulation — Product Code GZB

K233801 is an FDA 510(k) premarket notification submitted by Boston Scientific Neuromodulation for the device "Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation". The FDA issued a decision of Substantially Equivalent on August 23, 2024. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Boston Scientific Neuromodulation has at least 8 other 510(k) clearances on record.