Instrument, Manual, Specialized Obstetric-Gynecologic

What Is FDA Product Code KNA?

Instrument, Manual, Specialized Obstetric-Gynecologic is FDA product code KNA, Class 2, 21 CFR 884.4530.

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. 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.