QNS

Low Dead Space Needle, Single Lumen, Hypodermic

Product code
QNS
Device name
Low Dead Space Needle, Single Lumen, Hypodermic
Device class
Class 2
21 CFR
21 CFR 880.5570
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-10-25.

NumberDecision dateApplicantDevice nameSummary
K2429562024-10-25Ocuject, LLCLDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safet…PDF
K2317342024-03-08Tsk Laboratory International Japan KKSTERiJECT Low Dead Space, STERiJECT The Invisible Ne…PDF

2 summaries are archived here for direct download.

Official FDA classification page: QNS
Classification and pathway per current FDA publications. Data from openFDA (CC0).