FDA Product Code MJV: Device, Inflation, Middle Ear
Leading manufacturers include Exercore, LLC, Ningbo Albert Novosino Co., Ltd. and Earflo, Inc..
FDA 510(k) Cleared Device, Inflation, Middle Ear Devices (Product Code MJV)
About Product Code MJV - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code MJV since 1992, with 6 receiving FDA clearance (average review time: 117 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under MJV have taken an average of 165 days to reach a decision - up from 107 days historically. Manufacturers should account for longer review timelines in current project planning.
MJV devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →