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510(k) Data Aggregation

    K Number
    K012358
    Device Name
    CHIBA NEEDLE
    Manufacturer
    ISPG, INC.
    Date Cleared
    2001-10-15

    (82 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K052435
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Chiba needles are used in a variety of procedures including biopsy, nerve block, pericardiocentesis, transhepatic cholorangiography as well as other applications where injection and/or aspiration of fluids are required.

    Device Description

    Chiba Needle

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Chiba Needle." This letter confirms the device's substantial equivalence to legally marketed predicate devices and permits its marketing.

    However, this document does not contain the information required to answer your questions about acceptance criteria, device performance, study details, ground truth, or sample sizes.

    The letter is a regulatory approval document and does not include the results of performance studies, details about test sets, expert qualifications, or ground truth establishment. It merely states that the device is substantially equivalent for the stated indications for use.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer any of the specific questions (1-9) based on the input text.

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