Pure Global
FDA product code ESE

Larynx, Artificial (Battery-Powered)

Ear, Nose, Throat·Class 1·21 CFR 874.3375
US regulatory classifications
US Product Code (FDA)
ESE
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 874.3375
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Medical specialty
Ear, Nose, Throat
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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About this record

Larynx, Artificial (Battery-Powered) is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.