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Powered Insertion System For A Cochlear Implant Electrode Array

Page Type
Product Code
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.
Physical State
A powered device/system that may contain a motor and other software/hardware to assist in the insertion of a cochlear implant.
Technical Method
Device/system holds and advances the electrode array of cochlear implant.
Target Area
Cochlea in the inner ear.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.4450
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QQH is linked to regulation 21CFR874.4450, which does not seem to exist yet. It may be pending at the moment.

Powered Insertion System For A Cochlear Implant Electrode Array

Page Type
Product Code
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.
Physical State
A powered device/system that may contain a motor and other software/hardware to assist in the insertion of a cochlear implant.
Technical Method
Device/system holds and advances the electrode array of cochlear implant.
Target Area
Cochlea in the inner ear.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.4450
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QQH is linked to regulation 21CFR874.4450, which does not seem to exist yet. It may be pending at the moment.