510(k) K221376

Nalu Neurostimulation System by Boston Scientific Neuromodulation — Product Code GZB

K221376 is an FDA 510(k) premarket notification submitted by Boston Scientific Neuromodulation for the device "Nalu Neurostimulation System". The FDA issued a decision of Substantially Equivalent on June 10, 2022. 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.