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U.S. Department of Health and Human Services

Product Classification
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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 CodeQQH
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
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