FDA Product Code GZB: Stimulator, Spinal-cord, Implanted (pain Relief)
Leading manufacturers include Boston Scientific Neuromodulation.
FDA 510(k) Cleared Stimulator, Spinal-cord, Implanted (pain Relief) Devices (Product Code GZB)
About Product Code GZB - Regulatory Context
510(k) Submission Activity
139 total 510(k) submissions under product code GZB since 1978, with 139 receiving FDA clearance (average review time: 117 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under GZB have taken an average of 268 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.
GZB devices are reviewed by the Neurology panel. Browse all Neurology devices →