510(k) K202274

Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits by Boston Scientific Neuromodulation — Product Code GZB

K202274 is an FDA 510(k) premarket notification submitted by Boston Scientific Neuromodulation for the device "Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits". The FDA issued a decision of Substantially Equivalent on November 9, 2020. 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.