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510(k) K252339

iotaSOFT® Insertion System by Iotamotion, Inc. — Product Code QQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2026
Date Received
July 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Insertion System For A Cochlear Implant Electrode Array
Device Class
Class II
Regulation Number
874.4450
Review Panel
EN
Submission Type

A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.

Other clearances by Iotamotion, Inc.

  • DEN190055 — iotaSOFT Insertion System - Drive Unit, Controller and Accessories (October 1, 2021)

Other clearances for product code QQH

  • DEN190055 — iotaSOFT Insertion System - Drive Unit, Controller and Accessories (October 1, 2021)