Curette, Suction, Endometrial (And Accessories)

How Is HHK Classified?

Curette, Suction, Endometrial (And Accessories) is FDA product code HHK, Class 2, 21 CFR 884.1175.

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 2 clearances under this code; the FDA took a median of 157 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2014. None was by a company in China. The root causes the FDA records most often are Labeling design (1), No Marketing Application (1) and Packaging process control (1).

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