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510(k) Data Aggregation

    K Number
    K250993

    Validate with FDA (Live)

    Date Cleared
    2025-12-18

    (262 days)

    Product Code
    Regulation Number
    876.1500
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single Use Cytology Brush V BC-V600P-3010 is intended to be used to collect tissue specimens in the biliary system in combination with an endoscope.

    Device Description

    BC-V600P-3010 has been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with duodenoscopes. BC-V600P-3010 is inserted into the duodenoscope through an instrument channel to reach the target area, where, by rubbing the brush on the target area, specimens or cells can be collected. BC-V600P-3010 is then withdrawn from the duodenoscope channel with the collected samples.

    The handle is connected to operating wires. The grip on the handle portion controls the brush movement inside the tube. By pushing/pulling the handle, the brush at the distal end of the Subject device can be protruded from/drawn into the tube. Cells can be collected by moving over the target site with the brush.

    The BC-V600P-3010 consists of:

    A. Handle

    • Grip: used to push to extend the brush from the tube. Pull to retract the brush back into the tube.
    • Operation pipe: used to connect the grip with the wires so that it can transfer the force to push/pull the brush/distal tip.
    • Locking cap: used for fixing the location of the brush by turning the locking cap clockwise.
    • Injection port: Available to attach a syringe here to inject contract medium.
    • Hook: attached to the boot of the endoscope or ET Control Device V (sold separately).

    B. Insertion portion

    • Wires: connect operation pipe with brush and distal tip to push/pull the brush from/into the tube
    • Tube: works as the channel that the contrast media is injected through during use
    • V marking: gives the user an approximate indication of how far the instrument has been inserted into the endoscope,
    • Radiopaque marks: allow the distal end of the tube to be visualized on the X-ray monitor
    • Brush: used to brush the target area to collect samples.
    • Distal tip: When using a guidewire, the guidewire is inserted into the distal tip.
    AI/ML Overview

    N/A

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