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510(k) Data Aggregation

    K Number
    K253915

    Validate with FDA (Live)

    Date Cleared
    2025-12-18

    (10 days)

    Product Code
    Regulation Number
    878.4400
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MOVIVA is intended for:

    • argon plasma coagulation and ablation of the mucosa, with or without lesions.
    • needle-free injection and tissue-selective hydrodissection including lifting mucosa by injection into the submucosa.

    MOVIVA is indicated for use in endoscopic procedures.

    Device Description

    MOVIVA is a flexible, sterile, single use monopolar probe that combines the technologies of hydrosurgery and argon plasma coagulation (APC) in one instrument. Each function can be activated independently without the need to change instruments.

    It is used with an Erbe hydrosurgical unit and an Erbe APC unit in combination with an electrosurgical unit (ESU) Erbe VIO Model. The probe is inserted via the working channel of an endoscope with a working channel diameter larger than 2.8 mm. A form-coded marking near the probe tip ensures consistent positioning and orientation during the procedure.

    The hydrosurgical function is intended to deliver a pressurized fluid to create a fluid cushion beneath the tissue to be ablated which serves as a mechanical and thermal protection layer for the underlying tissue (muscularis). The electrosurgical (i.e. APC) function is intended for ablation of the lifted tissue. MOVIVA has a shaft length of 1.9 meters, a cable length of 3 meters and an outer diameter (OD) of 2.4 mm.

    MOVIVA is connected to the units via respective cables/tubing. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done using a footswitch.

    AI/ML Overview

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