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510(k) Data Aggregation

    K Number
    K030765
    Device Name
    HOBBS MISTIFIER SPRAY CATHETER
    Manufacturer
    HOBBS MEDICAL, INC.
    Date Cleared
    2003-06-09

    (90 days)

    Product Code
    OCX,EOQ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HOBBS MISTIFIER SPRAY CATHETER

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

    The Hobbs spray catheter is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing or staining mucosal tissue.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for the Hobbs Mistifier Medical Endoscopic Spray Catheter. It is a regulatory document from the FDA acknowledging substantial equivalence to predicate devices. This type of document does not contain the acceptance criteria or a study description as requested in the prompt.

    Therefore, I cannot extract the information required to populate the tables and answer the questions. The text focuses on regulatory classifications and general compliance, not on performance studies or acceptance criteria for a medical device's function.

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