Clamp, Circumcision

What Is FDA Product Code HFX?

Clamp, Circumcision is FDA product code HFX, Class 2, 21 CFR 884.4530.

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 1 clearance under this code; the FDA took 43 days from receipt to decision.

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 2005. None was by a company in China. The root causes the FDA records most often are Process control (4), No Marketing Application (2) and Device Design (1).

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