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510(k) Data Aggregation

    K Number
    K984417

    Validate with FDA (Live)

    Device Name
    BIPOLAR GRASPING FORCEPS BIQ+
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1999-02-24

    (76 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K945975,K955001,K971565,K955623,K944201
    Predicate For
    K140624
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for the OLYMPUS BIPOLAR FORCEPS. It focuses on regulatory approval and substantial equivalence to predicate devices. Crucially, this document does not contain any information regarding specific acceptance criteria, study details, or performance data of the device.

    Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically includes a general statement of intended use and a comparison to predicate devices, but it does not usually elaborate on detailed performance studies, acceptance criteria, or ground truth establishment.

    To answer your request, I would need a document that describes the specific testing and validation performed for the device's performance, which is not present in this 510(k) summary.

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