This page lists all FDA 510(k) submissions for Cover, Burr Hole devices (product code GXR). 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 Neurology FDA review panel. Browse all Neurology devices →

Data Source

FDA 510(k) public files . 4,872 total devices indexed.

Latest clearance: Mar 16, 2026

Product Code Info

Code	GXR
Device class	Class II
CFR	21 CFR 882.5250
Panel	Neurology

Verify on FDA.gov

View GXR classification on FDA.gov →