FDA Product Code PGW: Ear, Nose, And Throat Stereotaxic Instrument
Precise surgical navigation is essential in ENT surgery to avoid critical neurovascular structures. FDA product code PGW covers ear, nose, and throat stereotaxic instruments.
These navigation systems use preoperative CT or MRI data registered to the patient's anatomy to provide real-time spatial guidance during sinus surgery, skull base procedures, and cochlear implantation, reducing the risk of injury to the orbit, skull base, and cranial nerves.
PGW devices are Class II medical devices, regulated under 21 CFR 882.4560 and reviewed by the FDA Ear, Nose & Throat panel.
Leading manufacturers include Acclarent, Inc., Brainlab AG and Medtronic Navigation, Inc..
List of Ear, Nose, And Throat Stereotaxic Instrument devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Ear, Nose, And Throat Stereotaxic Instrument devices (product code PGW). 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 →