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510(k) Data Aggregation

    K Number
    K971146
    Device Name
    LAPARETTE
    Manufacturer
    RD CHUS, INC.
    Date Cleared
    1997-08-25

    (150 days)

    Product Code
    KNF
    Regulation Number
    884.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    RD CHUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAPARETTE is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of highfrequency electrical current, irrigate tissue and cavities, as well as suction fluids from the wound. This device is not intended for use in tubal sterilization procedures.
    Device Description
    The LAPARETTE is a hybrid device consisting of three reusable (Handle, Electrode-Cannula, and Insulated Sleeve) and two single use components (Cartridge and Sheath). All LAPARETTE components are supplied non-sterile, requiring sterilization by the health care facility before use. The LAPARETTE is sold both as a set and as individual products.
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