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510(k) Data Aggregation
K Number
DEN190055Device Name
iotaSOFT Insertion System - Drive Unit, Controller and Accessories
Manufacturer
Date Cleared
2021-10-01
(653 days)
Regulation Number
874.4450Why did this record match?
Product Code :
QQH
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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