Neurological Stereotaxic Instrument

How Is HAW Classified?

Neurological Stereotaxic Instrument is FDA product code HAW, Class 2, 21 CFR 882.4560.

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 1 clearance under this code; the FDA took 524 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 197 recalls under this product code since 2003. None was by a company in China. 15 are Class I, the most serious grade.

The root causes the FDA records most often are Software design (50), Device Design (38) and Nonconforming Material/Component (29). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.