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510(k) Data Aggregation

    K Number
    K172368
    Device Name
    Bipolar Micro-Coagulation Forceps
    Manufacturer
    Gunter Bissinger Medizintechnik GmbH
    Date Cleared
    2018-04-05

    (241 days)

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

    Gunter Bissinger Medizintechnik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bipolar Micro-Coagulation Forceps are intended to remove tissue and control bleeding.
    Device Description
    Bipolar Micro-Coagulation Forceps are electrosurgical tools available with different handles and different tip designs. The Bipolar Micro-Coagulation Forceps can be connected through an appropriate bipolar cable to an electrosurgical generator. The Bipolar Micro-Coagulation Forceps can be disassembled for cleaning and sterilization. The Bipolar Micro-Coagulation Forceps are delivered in unsterile condition and have to be sterilized prior to each use.
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    K Number
    K033177
    Device Name
    POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
    Manufacturer
    GUNTER BISSINGER MEDIZINTECHNIK GMBH
    Date Cleared
    2004-03-11

    (162 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUNTER BISSINGER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bipolar tissue coagulation in gynecologic and laparoscopic surgical procedures.
    Device Description
    The POWERGRIP coagulation forceps are designed for grasping, cutting and bipolar coagulation in minimally invasive surgery. The POWERGRIP handle actuates the jaws of the electrode inserts by means of a double-hinge and serves as the point of attachment for accessories (shafts, inserts, cables).
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