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510(k) Data Aggregation

    K Number
    K050090
    Device Name
    GEL MARK V
    Manufacturer
    SENORX, INC.
    Date Cleared
    2005-02-07

    (24 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K030090
    Predicate For
    K123911
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gel Mark V is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the 'Gel Mark V Biopsy Site Marker' as a substantially equivalent device. It does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results against specific criteria.

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