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510(k) Data Aggregation

    K Number
    K982401

    Validate with FDA (Live)

    Device Name
    PROSTATE BIOPSY NEEDLE
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    1998-09-08

    (60 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    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

    Prostate Biopsy Needles shall be single use only and are to be used by a urologist in a healthcare setting to obtain needle biopsies of the prostate.

    Device Description

    Not Found

    AI/ML Overview

    This is not a standalone AI device, therefore, the information requested is not applicable. The provided text is a 510(k) clearance letter for a Prostate Biopsy Needle, which is a medical device and not an AI algorithm. The document discusses regulatory clearance for marketing the device, not its performance based on AI algorithms or clinical studies in the context of AI.

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