PIK — Metabolic Neuromodulation System Class N
FDA product code PIK covers "Metabolic Neuromodulation System", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PIK
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Unknown
- Implant
- No
Definition
The device treats type 2 diabetes through hepatic nerve denervation. The metabolic neuromodulation system consists of a monopolar single electrode ablation catheter and radio frequency generator and is intended to ablate the sympathetic nerves surrounding the common hepatic artery.