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510(k) Data Aggregation

    K Number
    K041201
    Device Name
    ULTRACLIP II MR
    Manufacturer
    INRAD
    Date Cleared
    2004-06-03

    (27 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ultraclip II MR intended use is to attach to soft breast tissue at the time of an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called Ultraclip® II MR. It does not contain the detailed study information, acceptance criteria, or performance data of the device.

    Therefore, I cannot provide the requested information, which typically would be found in the manufacturer's submission or a separate scientific publication. This letter only confirms that the device has received market clearance based on substantial equivalence to a predicate device.

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