Hysteroscope (And Accessories)

What Is FDA Product Code HIH?

Hysteroscope (And Accessories) is FDA product code HIH, Class 2, 21 CFR 884.1690.

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 11 clearances under this code; the FDA took a median of 168 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 14 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Packaging change control (3), Nonconforming Material/Component (1) and Reprocessing Controls (1).

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