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510(k) Data Aggregation

    K Number
    K040780
    Date Cleared
    2005-02-10

    (321 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Peng's Multifunctional Operative Dissector consists of various types of disposable electrosurgical pencils which are adaptable to common brands of electrosurgical generators for cutting and coagulation to remove tissue and control bleeding by use of high frequency current. Several main models of the electrosurgical pencils can be utilized for suction, and blood, tissue debris, smoke can be removed from the surgical field.

    Device Description

    Peng's Multifunctional Operative Dissector (PMOD) consists of various types of disposable electrosurgical pencils which are adaptable to common brands of electrosurgical generators for cutting and coagulation to remove tissue and control bleeding by use of high frequency current. Several main models of the electrosurgical pencils can be utilized for suction, and blood, tissue debris, smoke can be removed from the surgical field.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the Peng's Multifunctional Operative Dissector (PMOD). It confirms substantial equivalence to predicate devices but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on regulatory approval and indications for use, without detailing performance metrics or study designs.

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