Low Dead Space Needle, Single Lumen, Hypodermic

What Is It?

A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features.

The device can be used by health care professions or for self-injection by the patient.

What Is FDA Product Code QNS?

Low Dead Space Needle, Single Lumen, Hypodermic is FDA product code QNS, Class 2, 21 CFR 880.5570.

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.