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510(k) Data Aggregation

    K Number
    K021247
    Device Name
    PNEUMOPERITONEUM INSUFFLATION NEEDLE
    Manufacturer
    MECTRA LABS, INC.
    Date Cleared
    2002-11-08

    (203 days)

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

    PNEUMOPERITONEUM INSUFFLATION NEEDLE

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

    Pneumoperitoneum Insufflation Needle is intended for use during Endoscopic procedures, to establish a pneumoperitoneum prior to abdominal endoscopy.

    Device Description

    Not Found

    AI/ML Overview

    This document (a 510(k) clearance letter) does not contain information on acceptance criteria or a study proving that the device meets acceptance criteria. It only indicates that the device (Pneumoperitoneum Insufflation Needle) is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

    Therefore, I cannot provide the requested information.

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