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510(k) Data Aggregation

    K Number
    K072525
    Device Name
    ZIPKNOT, MODEL 1017-3000
    Manufacturer
    MEDICINELODGE, INC.
    Date Cleared
    2007-10-05

    (28 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    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 MedicineLodge ZipKnot™ is indicated for use in approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the "MedicineLodge ZipKnot™ Suture Fixation Device." This letter does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The information typically found in such a study, including sample sizes, ground truth establishment, expert qualifications, and performance metrics, is not present in this regulatory correspondence. The letter primarily confirms that the device has been reviewed and deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested table and details based on the given input.

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