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510(k) Data Aggregation

    K Number
    K021886
    Date Cleared
    2002-06-19

    (12 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE

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

    The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus EVIS Video System Center, Olympus Light Sources, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.

    The Olympus GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.), Olympus Light Source, Olympus Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Olympus Electrosurgical Units (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for performing real-time endoscopic ultrasound imaging, EUS guided Fine Needle Aspiration (FNA), and for endoscopic ultrasound guided or assisted intervention within the upper digestive tract.

    Device Description

    The Olympus GF-UC140P-D05 Ultrasonic Gastrovideoscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Domier Surgical Products, Inc.) Olympus EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic ultrasonic imaging and treatment in the gastrointestinal wall, biliary and pancreatic ducts, and surrounding organs. These instruments also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract, i.e., pancreatic masses, mediastinal masses, and lymph nodes).

    The Olympus GF-UC30P Ultrasonic Gastrofiberscope has been designed to be used with the AI5200S and Envision Plus Ultrasound Imaging Systems (Dornier Surgical Products, Inc.) Olympus EVIS Video System Center, Light Source, Endo-Therapy Accessories (such as Aspiration Biopsy Needles) and Electrosurgical Unit (except for the case of Endoscopic Ultrasound (EUS) guided Electrosurgery) for endoscopic ultrasonic imaging and treatment in the gastrointestinal wall, biliary and pancreatic ducts, and surrounding organs. These instruments also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract, i.e., pancreatic masses, mediastinal masses, and lymph nodes).

    AI/ML Overview

    The provided text is a 510(k) summary for the Olympus Ultrasonic Gastrovideoscope GF TYPE UC140P-DO5 and Olympus Ultrasonic Gastrofiberscope GF TYPE UC30P. It describes the devices and their intended use but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting detailed clinical study results. It is likely that such study details would be found in other accompanying documents that are not included here, if they were required for this type of device.

    Therefore, I cannot provide the requested table and information based on the given text.

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