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    K Number
    K955764
    Device Name
    VALLEY FORGE BIPLOAR LOOP
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    1996-03-01

    (72 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VALLEY FORGE BIPLOAR LOOP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Valley Forge Scientific Corp., the manufacturer of several Malis solid state bipolar coagulation/cutting systems, now plans to introduce a new Bipolar Loop Electrode which Dr. Malis has used to core all types of brain and spinal cord neoplasms such as meningiomas, neuromas, and gliomas bloodlessly. The loop electrodes restrict cutting current flow outside of the loops to any other tissues and no current to any ground. Accordingly, there is no heat spread.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The text describes the history and features of a bipolar electrosurgical coagulator and its accessories, but it does not present any specific performance metrics, study designs, or results that would allow me to fill in the requested table and information points.

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