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510(k) Data Aggregation

    K Number
    K973590
    Device Name
    HEMORRELIEF DEVICE
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1998-02-05

    (136 days)

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

    HEMORRELIEF DEVICE

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

    The Hemorrelief device is intended to provide treatment for the relief of pain, itching, inflammation and bleeding of hemorrhoids by means of cryotherapy (controlled cold treatment).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for a device called "Hemorrelief" and its corresponding Indications for Use statement. It confirms the device's substantial equivalence to a predicate device but does not include the specifics of a study or performance metrics. Therefore, I cannot generate the requested information based on the input.

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