Cannula, Manipulator/Injector, Uterine

How Is LKF Classified?

Cannula, Manipulator/Injector, Uterine is FDA product code LKF, Class 2, 21 CFR 884.4530.

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 1 clearance under this code; the FDA took 280 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 13 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Process control (4), Device Design (3) and Component design/selection (3).

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