FDA Product Code ERL: Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Leading manufacturers include Stryker Corporation and Gyrus Acmi, Inc..
2
Total
2
Cleared
88d
Avg days
2021
Since
List of Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece devices cleared through 510(k)
2 devices
Cleared
Jan 19, 2022
Celeris, Disposable Sinus Debrider
Gyrus Acmi, Inc.
Ear, Nose, Throat
149d
Cleared
Jun 09, 2021
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
Stryker Corporation
Ear, Nose, Throat
27d
How to use this database
This page lists all FDA 510(k) submissions for Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece devices (product code ERL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Ear, Nose, Throat FDA review panel. Browse all Ear, Nose, Throat devices →