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510(k) Data Aggregation

    K Number
    K023450
    Device Name
    BIOPSY SITE TISSUE MARKER DEVICE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    2002-12-19

    (65 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K063193
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are intended to be used to mark an open or These devices are incended to be assabically mark the location of the biopsy site.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a Biopsy Site Tissue Marker Device. It does not contain information about acceptance criteria, study details, or performance metrics for the device. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study design, or performance from this document.

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