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510(k) Data Aggregation

    K Number
    K972119
    Device Name
    MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
    Manufacturer
    MEDOVATIONS, INC.
    Date Cleared
    1998-02-02

    (242 days)

    Product Code
    FAT
    Regulation Number
    876.5365
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)

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

    The Maloney and Hurst Bougies indications for use are for the dilation of: 1 - Upper esophageal webs. 2 - Lower esophageal rings. 3 - Caustic strictures. 4 - Peptic esophageal strictures. 5 - Temporary ease of esophageal carcinoma.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Tungsten Filled Maloney and Hurst Bougies." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The letter primarily states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    The "Indications For Use" section lists the medical conditions the device is intended to treat, but this is distinct from acceptance criteria or performance study results.

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