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510(k) Data Aggregation

    K Number
    K993055
    Device Name
    DEXIDE BIPOLAR FORCEPS II** DEVICE
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    1999-10-05

    (22 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K012279
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic and open bipolar procedures, to grasp, coagulate and transect tissues.

    Device Description

    The Dexide Bipolar Forceps II** device is a grasping, coagulating, and transecting bipolar forceps, which is intended for use in laparoscopic and open procedures. The device is intended for use with bipolar outputs of compatible electrosurgical generators.

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Dexide Bipolar Forceps II** device) and primarily discusses its intended use, classification, and substantial equivalence to previously marketed devices based on compliance with manufacturing and safety standards. It does not include specific performance data or a study report with quantitative acceptance criteria.

    Therefore, the requested tables and information cannot be extracted from the provided text.

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