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510(k) Data Aggregation

    K Number
    K974815
    Device Name
    MANAN(TM) INTRODUCER SHEATH/NEEDLE
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    1998-01-09

    (17 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K961216
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Manan™ Introducer Sheath/Needle is for the introduction of a .038 in. guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.

    Device Description

    The Manan Introducer Sheath/Needle is a 18 or 19 gauge trocar needle(Surgical grade 304 Stainless Steel) inside a 5 French radiopaque Teflon sheath. The sheath is tapered down to the trocar needle. The sheath accepts up to and including a .038 in. diameter guidewire. The usable length of this assembly is up to 20 cm.

    AI/ML Overview

    This document is about a 510(k) submission for a medical device called the "Manan™ Introducer Sheath/Needle" and does not contain information about acceptance criteria, device performance from a study, or any details related to AI or algorithm performance.

    The document is a notification of intent to market the device, a description of the device, and the FDA's letter of substantial equivalence. It compares the device to a predicate device based on its intended use and characteristics, not on a detailed performance study with acceptance criteria.

    Therefore, I cannot provide the requested information, as it is not present in the provided text.

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