Lithotriptor, Electro-Hydraulic

What Is FDA Product Code FFK?

Lithotriptor, Electro-Hydraulic is FDA product code FFK, Class 2, 21 CFR 876.4480.

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 2 clearances under this code; the FDA took a median of 177 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 21 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Error in labeling (7), Nonconforming Material/Component (3) and Software design (manufacturing process) (1).

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