BEUDAMED
    Product Code: OEK FDA class 2 21 CFR 876.4300

    Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia

    Gastroenterology, Urology

    The Water-Induced Thermotherapy System for Benign Prostatic Hyperplasia (product code OEK) is a gastroenterology/urology device used to treat symptomatic BPH through thermotherapy and dilation of prostatic tissue using heated water delivered to the prostatic urethra. The thermal energy induces controlled necrosis of obstructing prostatic tissue to relieve urinary symptoms. This device is FDA Class 2 under regulation 876.4300 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

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

    Product Code
    OEK
    Device Class
    FDA class 2
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    Definition

    Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia