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510(k) Data Aggregation

    K Number
    K992353
    Device Name
    BLUNT TIP TROCAR PORT
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Date Cleared
    1999-07-30

    (16 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K030512,K130121
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Blunt Tip Trocar Port has applications for surgery in the legs for establishment of a port of entry for endoscopic instruments.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry but this document is a letter from the FDA regarding the clearance of a medical device (Blunt Tip Trocar Port) and does not contain the detailed study information required to answer your request. The document confirms that the device can be marketed but does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
    3. Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
    4. Details on the type of ground truth used or the sample size and ground truth establishment for a training set.

    The letter is a regulatory approval, not a scientific study report.

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