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510(k) Data Aggregation

    K Number
    K040266
    Device Name
    CORE NEEDLE BIOPSY
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    2004-07-09

    (155 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CORE NEEDLE BIOPSY

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

    The Remington CenterFire is Intended for use in obtaining biopsies from soft tissue such as liver, kidney, prostate, breast, spleen and various soft tissue turnors. It is not intended for use in the bone.

    Device Description

    Remington CentreFire Biopsy Instrument

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Remington CentreFire Biopsy Instrument. It does not contain information about the acceptance criteria for a device's performance, nor does it describe any study that proves a device meets such criteria. Instead, it states that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance based on the provided text. The document is a regulatory approval letter, not a technical report detailing performance studies.

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