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., Stryker Corporation and Brainlab AG.
FDA 510(k) Cleared Ear, Nose, And Throat Stereotaxic Instrument Devices (Product Code PGW)
About Product Code PGW - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code PGW since 2014, with 36 receiving FDA clearance (average review time: 106 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under PGW have taken an average of 217 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.
PGW devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →