Metabolic Neuromodulation System

PIK · Not classified · Unknown

Classification

FDA Product Code: PIK
Device class: Not classified
Regulation: —
Review panel: GU
Medical specialty: Unknown
Submission type: 3
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown