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510(k) Data Aggregation

    K Number
    K040780
    Device Name
    ELECTROSURGICAL PENCILS
    Date Cleared
    2005-02-10

    (321 days)

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

    HANGZHOU SHUYOU MEDICAL INSTRUMENT COMPANY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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