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510(k) Data Aggregation

    K Number
    K252480

    Validate with FDA (Live)

    Device Name
    CE Deliver (DLV)
    Manufacturer
    Date Cleared
    2025-12-19

    (134 days)

    Product Code
    Regulation Number
    876.1300
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The disposable CE Deliver is a 2.5mm single-sheathed device indicated for transendoscopic delivery to the stomach or duodenum of CapsoCam Plus capsule endoscope (CE) devices. This device is intended for patients who are either unable to swallow the capsule or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

    Device Description

    The CapsoVision CE Deliver device is a single use, disposable, non-sterile catheter-based medical device designed to facilitate the transendoscopic delivery of the CapsoCam Plus Capsule Endoscope to the stomach or duodenum. CE Deliver is an accessory to the CapsoCam Plus, and is intended for use in patients who are unable to swallow a capsule endoscope or cannot pass it beyond the pylorus in a timely manner.

    The CE Deliver is comprised of a thin, flexible catheter with a Capsule Holder at its distal end and a Handle at its proximal end. The Capsule Holder is detachable from the Handle and Catheter by means of a threaded connector. CE Deliver is designed to be used in conjunction with a standard upper endoscope, through which the flexible catheter is inserted into the endoscope's instrument channel, upon which the Capsule Holder may be threaded onto the distal end. The device enables a user to securely load a capsule endoscope onto the distal Capsule Holder, guide it under direct endoscopic visualization to the desired location within the upper gastrointestinal tract, and then precisely release the capsule. After capsule release, the CE Deliver is retracted along with the endoscope, allowing the capsule to proceed naturally through the GI tract.

    The CE Deliver is compatible with upper endoscopes with an instrument channel diameter of 2.8mm or larger.

    AI/ML Overview

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