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510(k) Data Aggregation

    K Number
    DEN190055
    Device Name
    iotaSOFT Insertion System - Drive Unit, Controller and Accessories
    Manufacturer
    Date Cleared
    2021-10-01

    (653 days)

    Product Code
    Regulation Number
    874.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    IotaMotion, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 implant insertion. The iotaSOFT Insertion System is intended for use in cochlear implant patients ages 12 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 electrode array insertion speed. The system consists of a single-use, sterile drive unit (iotaSOFT™ DRIVE Unit) connected to a reusable, non-sterile touch screen control console and footpedal (iotaSOFT Controller and Accessories) (Figure 1).
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