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510(k) Data Aggregation

    K Number
    K253568

    Validate with FDA (Live)

    Device Name
    Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
    Manufacturer
    Fujifilm Corporation
    Date Cleared
    2026-02-06

    (81 days)

    Product Code
    FDS
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K193123
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic procedures or examinations.

    Device Description

    These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic procedures or examinations.

    This product is attached to the tip of our endoscope and is designed to prevent the mucosa from obstructing the surgical field of view during observation of the digestive tract or during endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), thereby ensuring a clear field of view during the procedure.

    AI/ML Overview

    N/A

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