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510(k) Data Aggregation

    K Number
    K974595

    Validate with FDA (Live)

    Device Name
    CUSHING BAYONET, INSULATED BIPOLAR FORCEP
    Manufacturer
    TITAN MFG., INC.
    Date Cleared
    1998-06-24

    (197 days)

    Product Code
    HTD,GEI
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K213386
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).

    Device Description

    Titan Cushing Bayonet Insulated Bipolar Forcep

    AI/ML Overview

    This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "Titan Cushing Bayonet Insulated Bipolar Forcep." It is a regulatory approval letter and does not contain information about acceptance criteria, device performance studies, or any of the other specific details requested in the prompt related to evaluating AI/device performance.

    Therefore, I cannot extract the requested information from the provided text.

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