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510(k) Data Aggregation

    K Number
    K070420
    Device Name
    BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2007-03-19

    (27 days)

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

    BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138

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

    The single use BioShield® - ERCP biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus and G5 and newer Fujinon gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the BioShield® - ERCP Biopsy Valve does not contain any information regarding acceptance criteria, device performance, or any studies conducted on the device's efficacy or safety.

    This document is a formal notification from the FDA confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a Pre-Market Approval (PMA) application. It focuses on regulatory classifications, general controls, and compliance requirements.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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