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510(k) Data Aggregation

    K Number
    K252247
    Device Name
    Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-10-16

    (90 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K902736,K011484,K153625
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single Use Injector NM-400/401 Series is intended to be used to perform endoscopic vascular or submucosal injection in the digestive tract with an endoscope.

    Device Description

    The Olympus Single-Use Injector NM-400/NM-401 is a sterile, disposable injection needle designed for use with Olympus endoscopes to perform endoscopic vascular or submucosal injections in the digestive tract. The device comprises a handle section, needle section, and sheath section, and operates via a slider mechanism that extends and retracts the needle. The needle is connected to an injection port through which fluids can be delivered to targeted tissue. The NM-400/NM-401 series includes various models with needle gauges ranging from 21G to 25G and working lengths from 1650 mm to 2700 mm, accommodating different clinical needs and endoscope compatibilities. The device is constructed from biocompatible materials including stainless steel (SUS304), polypropylene (PP), and perfluoroalkoxy (PFA), and is sterilized using ethylene oxide (EtO). It is intended for single use only.

    AI/ML Overview

    N/A

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