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510(k) Data Aggregation

    K Number
    K972562
    Device Name
    BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED
    Manufacturer
    ELECTROSCOPE, INC.
    Date Cleared
    1998-01-16

    (191 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product. The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.

    Device Description

    The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product. The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to Electroscope, Incorporated, for a Bipolar Electrosurgical Pencil. This type of document does not contain details about specific acceptance criteria or a study proving the device meets those criteria.

    The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, not necessarily a demonstration of clinical efficacy or extensive performance studies with detailed acceptance criteria as would be found in a Premarket Approval (PMA) application or a clinical trial report.

    Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval based on equivalence, not on a detailed performance study with acceptance criteria.

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