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510(k) Data Aggregation

    K Number
    K201833
    Device Name
    BiPad Hand Activated, Disposable Bipolar Electrocautery Cords
    Manufacturer
    BiPad Surgical, Inc.
    Date Cleared
    2020-07-31

    (29 days)

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

    BiPad Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BIPAD Hand Activated, Disposable Bipolar Electrocautery Cords are intended to connect an electrosurgical device to and electrosurgical generator. They are indicated for use with bipolar forceps during general surgical procedures.
    Device Description
    The BiPAD® Hand Activated, Disposable Bipolar Electrocautery Cords, Model BP105-C (Codman) and BP105-M (Medtronic) have been designed as an accessory to electrosurgical instruments where bipolar electrosurgical coagulation is desired during surgery. The device is a sterile, disposable, bipolar cord that connects to the electrosurgical generator on one end and the active instrument (bipolar forceps) on the other end. The cord has an integrated hand switch to activate the coagulating current of the RF generator. The device is intended for use with currently marketed Electrosurgical generators and bipolar surgical forceps to control bleeding.
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