Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012214
    Device Name
    CRYOPEN AND ACCESSORIES
    Date Cleared
    2002-04-26

    (284 days)

    Product Code
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIMEX BIOTECH, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended Use: Cryosurgical unit used for ablative type surgical technique Indications for use: Multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.
    Device Description
    The CryoPen system provides a means of freezing tissue without the use of cryogenic liquids or gases. The system consists of three hand-held freezing modules, a refrigeration unit, and disposable tips. When used properly, the system will deliver effective temperature for tissue ablation. The refrigeration component is the largest unit, and is used to lower the temperature of the CryoPen units to temperature of -100 C. It operates on 115 VAC obtained from conventional convenience outlets. The supporting housed in the refrigerator cabinet include a DC power source to indicate the temperature of the CryoPen units during cool down, and all other necessary control and electrical safety features. There are currently three different sizes of the hand-held modules: a 0.4 inch diameter unit, a 0.25 inch diameter unit, and a 0.19 inch diameter unit.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1