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 Fiagon GmbH, Acclarent, Inc. and Medtronic Navigation, Inc..