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510(k) Data Aggregation

    K Number
    K981966
    Device Name
    NOSEBLEED NOSECLIP
    Manufacturer
    MICHAEL M. KNOTT, M.D.
    Date Cleared
    1998-08-14

    (71 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NOSEBLEED NOSECLIP

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

    The treatment of simple anterior (front) nosebleeds by application of a noseclip to the external nose in adults and children. Not for use on infants.

    Device Description

    Existing respiratory noseclip is to be used to treat simple anterior (front) nosebleeds.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) submission and FDA clearance letter for a nosebleed noseclip. It discusses the device's intended use, classification, and substantial equivalence to predicate devices, but it does not detail specific performance metrics, study designs, or data to demonstrate "acceptance criteria" other than regulatory compliance.

    Therefore, I cannot provide the requested table or answer the questions regarding sample size, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies based on the input text.

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