Atlas FDA

QNS

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Low Dead Space Needle, Single Lumen, Hypodermic
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5570
Medical specialty
General Hospital
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.
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RecordFirmDate
LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (K242956)Ocuject, LLC2024-10-25
STERiJECT Low Dead Space, STERiJECT The Invisible Needle (K231734)Tsk Laboratory International Japan KK2024-03-08
EZ-Injec LDV Sterile Safety Needle (K210444)Poonglim Pharmatech, Inc.2021-02-16

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Every clearance here is in the API, with alerts when new ones post.