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510(k) Data Aggregation

    K Number
    K252646
    Device Name
    Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2025-10-24

    (64 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K994253,K180449
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single-use Fine Needle Biopsy (FNB) device NA-U210H has been designed to be used with an ultrasound endoscope for sampling of submucosal and extramural lesions within or adjacent the gastrointestinal tract.

    Device Description

    The Single-Use Fine Needle Biopsy (FNB) Device NA-U210H (SecureFlex) is a sterile, single-use fine needle biopsy device intended for use with an ultrasound endoscope to sample submucosal and extramural lesions within or adjacent to the gastrointestinal tract. It consists of:

    • Biopsy Needle Assembly: Handle, needle (19G, 22G, or 25G), and coiled sheath.
    • Aspiration System: VACLOK syringe and stopcock (FDA-cleared under K994253).

    The device features a bifurcated needle tip for enhanced tissue acquisition, echo-enhanced regions for ultrasound visibility, and is compatible with Olympus GF and TGF endoscopes with ≥2.8 mm channel diameter.

    AI/ML Overview

    N/A

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