System, Surgical, Computer Controlled Instrument

What Is This Device?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

How Is NAY Classified?

System, Surgical, Computer Controlled Instrument is FDA product code NAY, Class 2, 21 CFR 876.1500.

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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 248 recalls under this product code since 0012. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (67), Process change control (41) and Nonconforming Material/Component (28). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.