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510(k) Data Aggregation

    K Number
    K990662
    Device Name
    DISPOSABLE HEATING TUBING SET #7642HSES
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    1999-09-24

    (207 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 :

    DISPOSABLE HEATING TUBING SET #7642HSES

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

    This device is restricted to use by authorized expert personnel/physicians.

    The WISAP Disposable Heating Tube 7642HSE is a laparoscopic accessory to be used in connection with the WISAP (02 insufflator. This system serves for building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. The insufflation gas is preheated to body temperature by the disposable tubing.

    Device Description

    Laparoscopic Insufflator: Disposable Heating Tubing Set #7642 HSES

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device: a Disposable Heating Tubing Set #7642 HSES, used with a laparoscopic insufflator. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The 510(k) clearance process primarily establishes substantial equivalence to a legally marketed predicate device, rather than requiring detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) would.

    Therefore, I cannot fulfill your request for the specific details you outlined based on the given input text.

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