FDA Product Code ERL: Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Leading manufacturers include Stryker Corporation, Gyrus Acmi, Inc. and Zethon, Ltd..
FDA 510(k) Cleared Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece Devices (Product Code ERL)
About Product Code ERL - Regulatory Context
510(k) Submission Activity
91 total 510(k) submissions under product code ERL since 1978, with 91 receiving FDA clearance (average review time: 100 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under ERL have taken an average of 259 days to reach a decision - up from 98 days historically. Manufacturers should account for longer review timelines in current project planning.
ERL devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →