FDA Product Code EGJ: Device, Iontophoresis, Other Uses
Leading manufacturers include Acclarent, Inc., Top-Rank Health Care Co., Ltd. and Hidroxa Medical AB.
FDA 510(k) Cleared Device, Iontophoresis, Other Uses Devices (Product Code EGJ)
About Product Code EGJ - Regulatory Context
510(k) Submission Activity
73 total 510(k) submissions under product code EGJ since 1977, with 73 receiving FDA clearance (average review time: 187 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for EGJ submissions have been consistent, averaging 214 days recently vs 187 days historically.
EGJ devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →