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510(k) Data Aggregation

    K Number
    K961185
    Device Name
    DAUM BIOPSYNEEDLE
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1996-04-30

    (35 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K813338
    Why did this record match?
    Device Name :

    DAUM BIOPSYNEEDLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Daum BiopsyNeedle is intended for use in percutaneous or open surgical biopsies, including but not limited to, b10psy of breast, lung, kidney, liver, lymph nodes, and prostate.

    Device Description

    The Daum BiopeyNeedle is a standard soft-tissue biopsy needle.

    AI/ML Overview

    This 510(k) summary for the Daum BiopsyNeedle (K961185) does not contain information about acceptance criteria, device performance studies, or details relevant to AI/algorithm-based device evaluations. The document is concerned with demonstrating substantial equivalence to already marketed biopsy needles based on design, function, intended use, and material composition (titanium vs. stainless steel).

    Therefore, I cannot provide the requested information from the given text. The provided text is a regulatory submission for a medical device that does not involve AI or complex performance metrics beyond basic functional equivalence for a biopsy needle.

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