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510(k) Data Aggregation

    K Number
    K023706
    Device Name
    ULTROID HEMORRHOID MANAGEMENT SYSTEM
    Manufacturer
    ULTROID, LLC
    Date Cleared
    2003-01-14

    (71 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, III, III, IV.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Ultroid™ Hemorrhoid Management System. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a PMA (Premarket Approval) would for novel devices.

    Therefore, I cannot provide the requested information from this document.

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