BEUDAMED
    Product Code: PIK FDA not classified

    Metabolic Neuromodulation System

    Unknown

    The Metabolic Neuromodulation System is a novel device used to treat type 2 diabetes through hepatic nerve denervation, consisting of a monopolar single electrode ablation catheter and a radiofrequency generator intended to ablate the sympathetic nerves surrounding the common hepatic artery. It is classified as "Not Classified" (Class N) by the FDA, indicating it has not been assigned to an established classification category and may require a De Novo or novel regulatory pathway. The product code is PIK, reviewed by the Gastroenterology and Urology (GU) panel. This device is not implantable and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PIK
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    Unclassified Reason

    3