Catheter, Urological (Antimicrobial) and Accessories

What Is FDA Product Code MJC?

Catheter, Urological (Antimicrobial) And Accessories is FDA product code MJC, Class 2, 21 CFR 876.5130.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 254 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 23 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Packaging change control (8), Error in labeling (4) and Labeling mix-ups (3).

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