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510(k) Data Aggregation

    K Number
    K221385
    Device Name
    LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
    Manufacturer
    Ovesco Endoscopy AG
    Date Cleared
    2022-08-11

    (90 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The gel is an injection agent for endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD).

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria.

    The document is an FDA 510(k) clearance letter for a device called "LiftUp" (a gel for endoscopic mucosal resection and/or endoscopic submucosal dissection). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for the manufacturer.

    To answer your request, I would need a different document that details the performance study and acceptance criteria for the "LiftUp" device.

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