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510(k) Data Aggregation

    K Number
    K183309
    Device Name
    stentfix OTSC System Set
    Manufacturer
    Ovesco Endoscopy AG
    Date Cleared
    2019-10-22

    (327 days)

    Product Code
    PKL,OCZ
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    stentfix OTSC System Set

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

    Instrument for flexible endoscopy for fixation of metal stents in the gastrointestinal tract for use in adults only.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (stentfix OTSC System Set), not a study evaluating device performance or AI. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text.

    The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general controls, but not a specific performance study against acceptance criteria.

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