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510(k) Data Aggregation

    K Number
    K172479
    Device Name
    Amsel Occluder Device
    Manufacturer
    Amsel Medical
    Date Cleared
    2017-09-14

    (29 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 Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the Amsel Occluder Device. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance letter, not a clinical or performance study report.

    Therefore, I cannot provide the requested information. The sections of your request that relate to acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies are not present in this document.

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