FDA product code PIK: Metabolic Neuromodulation System
PIK is the FDA product code for metabolic neuromodulation system. It is a Not classified device, reviewed by the Gastroenterology and Urology panel. Devices under PIK reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Metabolic Neuromodulation System |
| Device class | Not classified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PIK devices
openFDA lists no recalls for product code PIK.
Frequently asked questions
What is FDA product code PIK?
PIK is the FDA product code for metabolic neuromodulation system. It is a Not classified device, reviewed by the Gastroenterology and Urology panel.
What device class is PIK?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PIK
- Run a recall and safety report across every PIK manufacturer
- Watch product code PIK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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