510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QQHClass II

Powered Insertion System For A Cochlear Implant Electrode Array

21 CFR 874.4450 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QQH is the FDA product code for Powered Insertion System For A Cochlear Implant Electrode Array, a class II device type, regulated under 21 CFR 874.4450. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QQH
Device name
Powered Insertion System For A Cochlear Implant Electrode Array
FDA 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.
Regulation
21 CFR 874.4450
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code QQH

By decision year
2 clearances under product code QQH with a decision year between 2021 and 2026, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QQH by decision year
YearClearances
20211
20261

Applicants with the most clearances

Product code QQH
Applicants holding the most 510(k) clearances under product code QQH
ApplicantClearances
Iotamotion Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code