Product code QQH

Device name: Powered Insertion System For A Cochlear Implant Electrode Array
Medical specialty: Ear, Nose, Throat
Device class: 2
Regulation number: 874.4450
Review panel: EN
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: 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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K252339	iotaSOFT® Insertion System	Iotamotion, Inc.	2026-01-09
DEN190055	iotaSOFT Insertion System - Drive Unit, Controller and Accessories	Iotamotion, Inc.	2021-10-01

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00850002960006	iotaSOFT Insertion System	Iotamotion, Inc.	2024-09-20
00850002960020	iotaSOFT Insertion System	Iotamotion, Inc.	2024-09-20
00850002960037	iotaSOFT Insertion System	Iotamotion, Inc.	2024-09-20
00850002960044	iotaSOFT Insertion System	Iotamotion, Inc.	2024-09-20
00850002960051	iotaSOFT Insertion System	Iotamotion, Inc.	2024-09-20
00850002960068	iotaSOFT Insertion System	Iotamotion, Inc.	2024-09-20

Related 510(k) Records#