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510(k) Data Aggregation

    K Number
    K101592
    Device Name
    ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
    Date Cleared
    2011-10-06

    (486 days)

    Product Code
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHENG MEDICAL, CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Erase Pen (RF Controller) is only used with the Erase Tip (Single Use Sterile Detachable Electrode Cartridge system) for thermal coagulation of soft tissue and peripheral nerves by creating radiofrequency (RF) lesions in nerve tissue. It is intended for use only by trained clinicians in hospital or clinical setting.
    Device Description
    The Erase Pen (hand-held Bi-Polar Radiofrequency battery operated controller) and the Erase Tip (single use, sterile detachable electrode cartridge system) is a hand-held Electrosurgical Device to locate and ablate nerves. The depth of the electrodes, the amount of RF energy. delivered, and the duration of energy applied control the size of the ablation.
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