Catheter, Urethral

What Is FDA Product Code GBM?

Catheter, Urethral is FDA product code GBM, Class 2, 21 CFR 876.5130.

How Does It Reach the US Market?

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 5 clearances under this code; the FDA took a median of 132 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 18 recalls under this product code since 2003. 1 was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Packaging process control (5), Employee error (1) and Process control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.