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510(k) Data Aggregation

    K Number
    K200684
    Device Name
    gastroduodenal FTRD Set
    Manufacturer
    Ovesco Endoscopy AG
    Date Cleared
    2020-06-02

    (78 days)

    Product Code
    PKL,FDI,KNS
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Instrument for flexible endoscopy, for full-thickness resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum.

    The gastroduodenal FTRD is indicated for the resection of lesions < 2.5 cm in the stomach and duodenum. Resection sizes may be less than 2.5 cm due to target tissue thickness and degree of fibrosis.

    For the resection of subepithelial tumors (SETs) the resection size is limited by the inner cap diameter.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the gastroduodenal FTRD Set. It does not contain information about acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment.

    The document describes the device's indications for use and lists general regulatory compliance requirements. It is a clearance letter, not a clinical study report or a summary of such a report.

    Therefore, I cannot provide the requested information based on the input text.

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