Low Dead Space Piston Syringe

What Is It?

A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.

How Is QNQ Classified?

Low Dead Space Piston Syringe is FDA product code QNQ, Class 2, 21 CFR 880.5860.

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 135 days from receipt to decision.