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510(k) Data Aggregation

    K Number
    K252339

    Validate with FDA (Live)

    Device Name
    iotaSOFT® Insertion System
    Manufacturer
    Iotamotion, Inc.
    Date Cleared
    2026-01-09

    (165 days)

    Product Code
    QQH
    Regulation Number
    874.4450
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    4 - 12
    Reference & Predicate Devices
    DEN190055
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The iotaSOFT® Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of array insertion. The iotaSOFT Insertion System is indicated for use in cochlear implant patients ages 4 years and older during cochlear implant procedures using either a round window or cochleostomy approach.

    Device Description

    The iotaSOFT® Insertion System is designed to assist the surgeon during cochlear implantation by controlling the speed of electrode array insertion. The iotaSOFT Insertion System is designed to reduce electrode array insertion variability and forces. The system includes:

    • Sterile single-use Drive Unit (IM-00 or IM-05)
    • Reusable, nonsterile touch screen console and footpedal interface

    The Drive Unit is mounted on a standard surgical equipment Rolling Stand and is compatible with commercially available cochlear implant arrays from each of the 3 CI manufacturers distributing product in the U.S.

    AI/ML Overview

    N/A

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