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510(k) Data Aggregation

    K Number
    K990231

    Validate with FDA (Live)

    Device Name
    WILTEK HOT BIOPSY FORCEPS
    Manufacturer
    WILTEK MEDICAL, INC.
    Date Cleared
    1999-04-13

    (78 days)

    Product Code
    KGE
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wiltek Hot Biopsy Forcep is intended for transendoscopic biopsy of the GI tract.

    Device Description

    Wiltek Hot Biopsy Forcep

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an Indications For Use statement for the Wiltek Hot Biopsy Forcep. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot provide the requested information based on the input text.

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