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510(k) Data Aggregation

    K Number
    K252457

    Validate with FDA (Live)

    Device Name
    Disposable Distal End Tape Hood
    Manufacturer
    Shanghai SeeGen Photoelectric Technology Co., Ltd.
    Date Cleared
    2026-01-30

    (178 days)

    Product Code
    FDF
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K162749
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is intended to be used in combination with compatible colonoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

    This product needs to be cut and connected to the endoscope tip of 9mm to 14mm, and medical tape needs to be prepared in advance to fix it into a cylindrical shape.

    Device Description

    This product is intended to be attached to an endoscope.

    The Disposable Distal End Tape Hood is installed at the tip of the endoscope to assist the endoscope in a clearer observation. It can push away the mucosa and keep a certain distance between the lens and the mucosa, thus maintaining the field of view.

    AI/ML Overview

    N/A

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