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510(k) Data Aggregation

    K Number
    K250145
    Device Name
    Biopsy Port Adapter
    Manufacturer
    EndoSound, Inc.
    Date Cleared
    2025-10-17

    (269 days)

    Product Code
    ODC
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K210342,K163248
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The single-use Biopsy Port Adapter (BPA) converts the biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port. This adapter supports luer-lock-connector fine needle biopsy (FNB) and fine needle aspiration (FNA) devices used during an EndoSound EUS endoscopic procedure, while maintaining scope suction.

    Device Description

    The Biopsy Port Adapter (BPA) converts the non-luer-lock biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port to support Fine Needle Biopsy (FNB) and Fine Needle Aspiration (FNA) luer endoscopic procedures using luer-lock-type needles. The adapter also seals the port during use and maintains the ability of the scope to provide suction throughout the procedure. The BPA works in tandem with the EndoSound Vision System™ when performing ultrasound-guided FNA and FNB procedures.

    AI/ML Overview

    N/A

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