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510(k) Data Aggregation

    K Number
    K021142
    Device Name
    ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
    Manufacturer
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Cleared
    2002-10-01

    (175 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

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

    To pass fluid to and from the urinary bladder after prostatectomy.

    Device Description

    Fortune Medical Instruments Corp. All Silicone 2-Way/3-Way Hematuria Catheters Models 4861, 4862, 4863, 4864 and 4865.

    AI/ML Overview

    I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for a device based on the provided text. The document is a 510(k) clearance letter from the FDA, which confirms that a medical device (Fortune All-Silicone 2-Way and 3-Way Hematuria Catheter Models) is substantially equivalent to a legally marketed predicate device.

    This type of letter does not include information about specific acceptance criteria or an analytical study with performance metrics, sample sizes, expert qualifications, or ground truth methods. It simply states that the FDA has reviewed the premarket notification and determined substantial equivalence, allowing the device to be marketed.

    Therefore, the requested information (such as a table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, or training set details) is not present in the provided text.

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