Unit, Cryosurgical, Accessories

How Is GEH Classified?

Unit, Cryosurgical, Accessories is FDA product code GEH, Class 2, 21 CFR 878.4350.

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 2 clearances under this code; the FDA took a median of 148 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 106 recalls under this product code since 2002. None was by a company in China. 3 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (21), Nonconforming Material/Component (11) and Process control (10). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.