BEUDAMED
    Product Code: LNL FDA unclassified

    Stimulator, Electrical For Sperm Collection

    Unknown

    Stimulator, Electrical for Sperm Collection is an electrical stimulation device used to induce ejaculation in males who cannot ejaculate normally due to spinal cord injury or neurological dysfunction, enabling collection of sperm for assisted reproduction. This device is currently unclassified by the FDA, meaning its formal regulatory classification is pending. The product code is LNL; no regulation number or medical specialty has been assigned. The review panel is Gastroenterology/Urology.

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

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    Basic Information

    Product Code
    LNL
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Unclassified Reason

    1

    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
    K962379 SEAGER ELECTROEJACULATOR