BEUDAMED
    Product Code: MHD FDA class 2 21 CFR 880.5725

    Pump, Infusion, Gallstone Dissolution

    General Hospital

    The gallstone dissolution infusion pump is a general hospital device used to deliver a continuous controlled infusion of cholesterol solvent (such as methyl tert-butyl ether) directly into the gallbladder via a catheter for the purpose of dissolving cholesterol gallstones in patients who are not surgical candidates. It is classified as FDA Class II under 21 CFR 880.5725 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MHD and the device is not implanted. Full GMP quality system requirements apply.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    MHD
    Device Class
    FDA class 2
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K993907 VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22