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510(k) Data Aggregation

    K Number
    K142248
    Device Name
    Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope
    Manufacturer
    Urologix, Inc.
    Date Cleared
    2015-02-20

    (190 days)

    Product Code
    GEI, KNS
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Urologix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prostiva RF Therapy System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm³.
    Device Description
    Prostiva RF Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The Prostiva RF Therapy System uses precisely focused radio frequency (RF) energy to ablate prostate tissue.
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