Powered Insertion System For A Cochlear Implant Electrode Array
The Powered Insertion System for a Cochlear Implant Electrode Array is a prescription ear, nose, and throat device used to assist in the precise placement of an electrode array into the cochlea during cochlear implant surgery, providing controlled, powered insertion to minimize trauma to delicate cochlear structures. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 874.4450 in the Ear, Nose, Throat specialty. It carries product code QQH and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QQH
- Device Class
- FDA class 2
- Regulation Number
- 874.4450
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.