Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061541
    Device Name
    KSEA BIPOLAR ELECTROTOME
    Manufacturer
    KSEA
    Date Cleared
    2006-08-21

    (77 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    KSEA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KSEA Bipolar Electrotome is intended for use in combination with a resectoscope and a sheath by qualified surgeons to resect, ablate or coagulate tissue via a high frequency electrical current waveform during various endoscopic urological procedures. These procedures include bladder tumor diagnosis and resection, transurethral prostatic and bladder biopsy, transurethral prostatic resection, removal of urethral calculus, and treatment of vesical neck constriction.
    Device Description
    The KSEA Bipolar Electrotome is a manual surgical device, featuring a working element, a single-use cutting loop, and a high frequency cable. It is designed to be used with a 4 mm resectoscope and a 24 or 26 Fr resectoscope sheath.
    Ask a Question

    Page 1 of 1