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510(k) Data Aggregation

    K Number
    K260255

    Validate with FDA (Live)

    Device Name
    AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
    Manufacturer
    Aventix Medical, Inc.
    Date Cleared
    2026-03-27

    (58 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    All
    Reference & Predicate Devices
    K221907,K162810
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AVENTIX™ PFX System is an electrosurgical system intended to generate Pulsed Field Energy (PFE) for use with the NOVOCLEAR™ Device. The AVENTIX™ PFX System is indicated for use in small clinics, offices and/or hospital environments.

    The NOVOCLEAR™ Device is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including the posterior nasal nerve distribution in patients with chronic rhinitis.

    Device Description

    The AVENTIX™ PFX System and NOVOCLEAR™ Device include the following components:

    1. NOVOCLEAR™ Device - a single use, hand-held device capable of delivering pulsed field energy (PFE) to targeted tissue. The NOVOCLEAR™ Device consists of a handle, a dome-like electrode and an electrical connector. The dome-like electrode delivers PFE and is angled to approximately 60 degrees, to aid access to the targeted tissue. An electrical connector is used to connect the NOVOCLEAR™ Device to the AVENTIX™ Generator.

    2. AVENTIX™ Generator - generates predefined PFE output, which is delivered to the NOVOCLEAR™ Device dome-like electrode tip.

    3. AVENTIX™ Controller – Performs validation of the NOVOCLEAR™ Device prior to use, changes the status of the Generator between armed and disarmed, and receives and displays parameters from the generator to the user.

    4. Footswitch – for selective activation by the user to initiate PFE output.

    The NOVOCLEAR™ Device delivers pulsed field energy (PFE) to soft tissues in the nasal airway, including the posterior nasal nerve distribution. Non-clinical testing was performed to support safety and performance for the labeled use.

    AI/ML Overview

    N/A

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