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510(k) Data Aggregation

    K Number
    K990912
    Device Name
    MTP EXTRACTION BAG
    Manufacturer
    MTP MEDICAL TECHNICAL PROMOTION GMBH
    Date Cleared
    1999-06-09

    (83 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K991730,K232490
    Why did this record match?
    Reference Devices :

    K991730, K232490

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

    The MTP Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.

    The Extraction Bag for use in Laparoscopy is intended for use by qualified surgeons during laparoscopic procedures, including cholecystectomy, appendectomy, nephrectomy, lymphadenectomy, intestinal resection, oophorocystectomy and myomectomy.

    Device Description

    The MTP Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The body contact materials are high density polyethylene and polyurethane film.

    AI/ML Overview

    The provided document is a 510(k) summary for the MTP Extraction Bag, a medical device used in laparoscopic surgery. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Medical devices like the MTP Extraction Bag are typically evaluated for substantial equivalence to a predicate device rather than undergoing performance studies that would generate the type of data requested in the prompt. Therefore, I cannot extract the requested information from this document.

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