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510(k) Data Aggregation

    K Number
    K031014
    Device Name
    HI-FLO THERME PNEU 45, WISAP #7083, 7083V
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    2003-06-27

    (88 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 :

    HI-FLO THERME PNEU 45, WISAP #7083, 7083V

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

    The WISAP Multi Hi-Flo Therme Pneu 45 may only be used for building up a pneumoperitoneum with CO2Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a laparoscopic insufflator (HI-FLO Therme Pneu 45). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the given context.

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