Cover, Burr Hole

What Is FDA Product Code GXR?

Cover, Burr Hole is FDA product code GXR, Class 2, 21 CFR 882.5250.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 537 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2021. None was by a company in China. The root cause the FDA records most often is Process control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.