510(k) DEN190055
DEN190055 is an FDA 510(k) premarket notification submitted by Iotamotion, Inc. for the device "iotaSOFT Insertion System - Drive Unit, Controller and Accessories". The FDA issued a decision of De Novo Granted on October 1, 2021. The device falls under product code QQH (Powered Insertion System For A Cochlear Implant Electrode Array), a Class II device regulated under 21 CFR 874.4450. Iotamotion, Inc. has at least 1 other 510(k) clearance on record.
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.