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510(k) Data Aggregation

    K Number
    K101080
    Device Name
    NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX
    Manufacturer
    EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN
    Date Cleared
    2010-06-21

    (63 days)

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

    EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar and monopolar coagulation for general surgery where coagulation of soft tissue is needed. The bipolar forceps are used with the bipolar and the monopolar forceps with the monopolar output of standard electrosurgical generators. The EGON FAULHABER Bipolar and Monopolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended are: General surgery, Laryngeal coagulation, Orthopedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynecological coagulation (except for use in female sterilization), Urological coagulation, Ear-, Nose- and Throat coagulation.
    Device Description
    The EGON:FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are reusable devices and provided non sterile. They must be cleaned and sterilized before use. Bipolar Forceps: The branches are made of stainless steel insulated with Polyamide (PA) except for the tip of the instrument. The EGON FAULHABER Bipolar Forceps are of the same basic design with differences in tip sizes and handle styles. Two types of electrical plugs are available: flat plug, or 2 pin plug. The Bipolar Forceps are to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. Non-Stick Bipolar Forceps: The Non-Stick Bipolar Forceps have the same characteristics as the Bipolar Forceps except for the special material with excellent thermal properties, applied to the tips of the forceps. Thereby difficult and time consuming cleaning of the forceps during an operation can be avoided and enables non-stop working. The non-stick effect is permanently ensured and will not be reduced, even if subject to frequent sterilization. Monopolar Forceps: The branches are made of stainless steel insulated with Polyamide (PA) except for the tip of the instrument. The EGON FAULHABER Monopolar Forceps are of the same basic design with differences in tip sizes and handle styles. They are available with or with out plug socket. The Monopolar Forceps can be connected through a suitable monopolar cable with the monopolar output of an electrosurgical generator. Monopolar Forceps must only be used with monopolar coagulation current.
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