FDA Product Code ETN: Stimulator, Nerve
FDA product code ETN covers nerve stimulators used in otolaryngology and skull base surgery.
These devices deliver controlled electrical stimuli to identify and map cranial nerves intraoperatively — particularly the facial nerve during parotid, acoustic neuroma, and mastoid surgery — reducing the risk of permanent nerve injury. Real-time electromyographic feedback alerts the surgeon when the probe is near nerve tissue.
ETN devices are Class II medical devices, regulated under 21 CFR 874.1820 and reviewed by the FDA Ear, Nose & Throat panel.
Leading manufacturers include Medtronic Xomed, Inc., Nvision Biomedical Technologies, Inc. and Biosys Biyomedikal Muhendislik San. VE Tic. A.S..
FDA 510(k) Cleared Stimulator, Nerve Devices (Product Code ETN)
About Product Code ETN - Regulatory Context
510(k) Submission Activity
97 total 510(k) submissions under product code ETN since 1978, with 97 receiving FDA clearance (average review time: 143 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA Review Time
Recent submissions under ETN have taken an average of 221 days to reach a decision - up from 139 days historically. Manufacturers should account for longer review timelines in current project planning.
ETN devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →