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510(k) DEN190055

iotaSOFT Insertion System - Drive Unit, Controller and Accessories by Iotamotion, Inc. — Product Code QQH

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 1, 2021
Date Received
December 18, 2019
Clearance Type
Direct
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.

  • K252339 — iotaSOFT® Insertion System (January 9, 2026)

Other clearances for product code QQH

  • K252339 — iotaSOFT® Insertion System (January 9, 2026)