Lithotriptor, Extracorporeal Shock-Wave, Urological

How Is LNS Classified?

Lithotriptor, Extracorporeal Shock-Wave, Urological is FDA product code LNS, Class 2, 21 CFR 876.5990.

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 2 clearances under this code; the FDA took a median of 365 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2015. None was by a company in China. The root cause the FDA records most often is Software design (1).

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