DeviceClearance

Product code QNS— General Hospital

EZ-Injec LDV Sterile Safety Needle

Classification name
Low Dead Space Needle, Single Lumen, Hypodermic
Device class
Class 2
Regulation
21 CFR 880.5570
Advisory panel
General Hospital
Total cleared
3
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QNS under 21 CFR 880.5570, via openFDA

Market context for product code QNS

FDA has cleared 3 devices under product code QNS between 2021 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNS

Recent clearances under product code QNS

Data sourced from openFDA. This site is unofficial and independent of the FDA.