FDA Product Code GZF: Stimulator, Peripheral Nerve, Implanted (pain Relief)
Leading manufacturers include Bioventus, LLC, Boston Scientific Neuromodulation and Curonix.
FDA 510(k) Cleared Stimulator, Peripheral Nerve, Implanted (pain Relief) Devices (Product Code GZF)
About Product Code GZF - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code GZF since 1991, with 24 receiving FDA clearance (average review time: 181 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GZF have taken an average of 270 days to reach a decision - up from 163 days historically. Manufacturers should account for longer review timelines in current project planning.
GZF devices are reviewed by the Neurology panel. Browse all Neurology devices →