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510(k) Data Aggregation

    K Number
    K250187
    Device Name
    Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-10-07

    (258 days)

    Product Code
    KGE
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K101657
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DISPOSABLE HOT BIOPSY FORCEPS FD-210U/FD-230U are intended to be used to collect tissue samples within the digestive tract using high-frequency current under endoscopic observation in combination with an endoscope.

    Device Description

    The Disposable Hot Biopsy Forceps have been designed to collect tissue endoscopically within the digestive tract using high-frequency current under endoscopic observation. The Disposable Hot Biopsy Forceps consists of a handle section and insertion portion. The cups in the distal end of insertion portion are activated in the open and closed position by maneuvering the slider in the handle. The cup shapes are provided in either alligator jaw-step (FD-210U) or oval type (FD-230U).

    The subject device is connected to a compatible electrosurgical device by an A-cord. The A-cord jack is connected to the plug on the handle of the subject device. The target tissue is held by the cups. The tissue is subjected to high frequency electric current transmitted from the plug which allows for collecting tissue.

    The subject device has the same technological characteristics and similar design as the applicable predicate device.

    AI/ML Overview

    N/A

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