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510(k) Data Aggregation

    K Number
    K062725
    Device Name
    MAXIFLEX-SEMI FLEX SCOPE
    Manufacturer
    TECHNOLOGY DELIVERY SYSTEMS, INC.
    Date Cleared
    2006-09-29

    (16 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K111480
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MaxiFlex Semi Flex Scopes™.are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but this document is a 510(k) premarket notification letter from the FDA to Technology Delivery Systems, Inc. regarding their MaxiFlex-Semi Flex Scope.

    It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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