K201618 - Nalu Neurostimulation SCS system
(FDA 510(k) Clearance)

K201618 is an FDA 510(k) clearance for the Nalu Neurostimulation SCS system, a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II — Special Controls, product code GZB), submitted by Boston Scientific Neuromodulation (Valencia, US). The FDA issued a Cleared decision on July 15, 2020, 30 days after receiving the submission on June 15, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5880.