Catheter, Nephrostomy
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Guangdong.
How Is LJE Classified?
Catheter, Nephrostomy is FDA product code LJE, unclassified.
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 196 days from receipt to decision on them.
What Has Gone Wrong With It?
The FDA has recorded 12 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Process control (4), No Marketing Application (2) and Labeling mix-ups (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.