510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QNSClass II

Low Dead Space Needle, Single Lumen, Hypodermic

21 CFR 880.5570 / General Hospital
FDA source (opens on fda.gov)

QNS is the FDA product code for Low Dead Space Needle, Single Lumen, Hypodermic, a class II device type, regulated under 21 CFR 880.5570. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QNS
Device name
Low Dead Space Needle, Single Lumen, Hypodermic
FDA 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.
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QNS

By decision year
3 clearances under product code QNS with a decision year between 2021 and 2024, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QNS by decision year
YearClearances
20211
20242

Applicants with the most clearances

Product code QNS
Applicants holding the most 510(k) clearances under product code QNS
ApplicantClearances
Ocuject, LLC1
Poonglim Pharmatech, Inc.1
TSK Laboratory International Japan KK1

Companies listing this code with FDA

Companies whose registered establishments list this code