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510(k) Data Aggregation

    K Number
    K090121
    Device Name
    PRE-FILLED CATHETER INFLATION SYRINGE
    Manufacturer
    AVAIL MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-04-15

    (84 days)

    Product Code
    KNY
    Regulation Number
    876.5130
    Type
    Special
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K952414
    Why did this record match?
    Device Name :

    PRE-FILLED CATHETER INFLATION SYRINGE

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

    The Avail Sterile, Latex Free, Water Filled Syringe is intended to be used to provide sterile water for catheter inflation after insertion.

    Device Description

    The Avail Sterile, Latex Free, Water Filled Syringe is a sterile, single patient use, disposable device that is substantially equivalent to the predicate device and other pre-filled syringes. The device is designed for catheter inflation only and is intended for single patient use as was the predicate device.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or a study proving that a device meets acceptance criteria. The documents are a 510(k) summary and an FDA clearance letter for a pre-filled catheter inflation syringe. They focus on establishing substantial equivalence to a predicate device and outlining regulatory information.

    Therefore, I cannot populate the requested tables and information based on the provided text.

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