BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Urocross Expander System (Model Numbers ES2018 and ES3025)

    K Number: K253525 · Decision Mar 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    119

    Basic Information

    Device Name
    Urocross Expander System (Model Numbers ES2018 and ES3025)
    K Number
    K253525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5510
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prodeon Medical, Inc.
    Date Received
    November 13, 2025
    Decision Date
    March 12, 2026
    Product Code
    QKA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

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