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510(k) Data Aggregation

    K Number
    K992190
    Device Name
    CORE POUCH
    Manufacturer
    CORE DYNAMICS, INC.
    Date Cleared
    1999-09-01

    (64 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CORE POUCH

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

    The CORE Pouch is used when the surgeon desires to collect and remove tissue during laparoscopic procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a medical device called "Core Pouch" and a research proposal on computer vision, neither of which contains information about acceptance criteria or a study proving device performance as requested. The document does not describe any specific performance characteristics, clinical studies, or acceptance criteria for the "Core Pouch" device. It primarily states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested table or detailed study information based on the input given.

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