Device |
powered insertion system for a cochlear implant electrode array |
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 |
Product Code | QQH |
Premarket Review |
Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
874.4450
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |