BEUDAMED
    Product Code: MDG FDA class 2 21 CFR 884.4530

    System, Intrafallopian Cannula

    Obstetrics/Gynecology

    The intrafallopian cannula system is an obstetrics/gynecology device used to access and cannulate the fallopian tubes, typically for procedures such as fallopian tube recanalization in patients with proximal tubal obstruction causing infertility. It is classified as FDA Class II under 21 CFR 884.4530 within the Obstetrics/Gynecology specialty, requiring 510(k) premarket clearance. The product code is MDG and the device is not implanted. Full GMP quality system requirements apply.

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    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MDG
    Device Class
    FDA class 2
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    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
    K000620 PBN FALLOPIAN TUBE CATHETER SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.