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510(k) Data Aggregation

    K Number
    K251996

    Validate with FDA (Live)

    Device Name
    ENTire IRE System
    Manufacturer
    Entire Medical , Ltd.
    Date Cleared
    2026-01-14

    (201 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K233705
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Irreversible Electroporation (IRE) System Generator is indicated for the surgical ablation of soft tissue, specifically for otorhinolaryngology (ENT) indications.

    Device Description

    The ENTire IRE System includes a reusable electrosurgical generator activated by a foot pedal and single-use handpieces which are provided sterile. The ENTire IRE System utilizes irreversible electroporation ("IRE"), a nonthermal ablation technology that delivers high-voltage, low-energy electrical pulses to tissue via bipolar electrodes. The system generates irreversible nanopores in the cell membranes, altering the cell membrane characteristics, and inducing apoptosis. The dead cells are then resorbed leading to tissue reduction.

    AI/ML Overview

    N/A

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