Laparoscope, Gynecologic (And Accessories)

How Is HET Classified?

Laparoscope, Gynecologic (And Accessories) is FDA product code HET, Class 2, 21 CFR 884.1720.

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 3 clearances under this code; the FDA took a median of 206 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 19 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (5), Process control (4) and Device Design (3).

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