Endoscopic Injection Needle, Gastroenterology-Urology

What Is This Device?

inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.

What Is FDA Product Code FBK?

Endoscopic Injection Needle, Gastroenterology-Urology is FDA product code FBK, Class 2, 21 CFR 876.1500.

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 14 clearances under this code; the FDA took a median of 180 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 42 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Process change control (9), Process control (7) and Employee error (1).

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