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510(k) Data Aggregation

    K Number
    K982313
    Device Name
    HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
    Manufacturer
    WECK CLOSURE SYSTEMS
    Date Cleared
    1998-08-10

    (40 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS

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

    Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where I iorizon ligating this are the best clip size, type and material based upon experience, judgement and needs.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the Horizon Ligation Clips, dated August 10, 1998. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about acceptance criteria, device performance, results of a study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested information based on the input document. The document is primarily a regulatory approval letter and does not include the detailed technical study information that would be necessary to answer your questions.

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