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510(k) Data Aggregation

    K Number
    K111955
    Device Name
    MEDLINE PNEUMOPERITONEUM NEEDLE
    Manufacturer
    MEDLINE, INDUSTRIES, INC.
    Date Cleared
    2011-11-16

    (128 days)

    Product Code
    HIF,FHO
    Regulation Number
    884.1730
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE PNEUMOPERITONEUM NEEDLE

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

    The Medline Pneumoperitoneum Needle has applications in gynecologic and abdominal endoscopic procedures for establishment of a pneumoperitoneum.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) substantial equivalence letter from the FDA for a medical device called the "Medline Pneumoperitoneum Needle." This document establishes the device's regulatory classification and outlines general controls and regulations. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information. The letter is a regulatory approval document and not a scientific study report.

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