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510(k) Data Aggregation

    K Number
    K232407
    Device Name
    Cautery Protective Actuation System (CPAS)
    Date Cleared
    2023-10-06

    (57 days)

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

    Safer Surgeries Medical Devices, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cautery Protective Actuation System (CPAS) is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation. The CPAS device includes a safety cover intended to prevent inadvertent actuation of the monopolar electrocautery device, and to prevent secondary burns from a hot tip.
    Device Description
    The Cautery Protective Actuation System device is a sterile, single-use, monopolar electrocautery pen intended to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation. The C-PAS device has a retractable cover, which functions to reduce the risk of inadvertent actuation that can result in burns, fires, patient impalement, or secondary contact from exposure to a hot tip. In the resting position, the cover guards both the tip and the rocker switch, and thereby prevents inadvertent actuation of the device. The "dead-man" trigger forces the user to squeeze the trigger in order to retract the safety cover and thereby access the rocker switch to actuate the monopolar electrocautery pen. The C-PAS device functions identically to a standard, monopolar electrocautery pen with the additional benefits of a retractable, protective shield.
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