Cleared Traditional

EZ-Injec LDV Sterile Safety Needle

K210444 · Poonglim Pharmatech, Inc. · General Hospital
Feb 2021
Decision
—
Days
Class 2
Risk

About This 510(k) Submission

K210444 is an FDA 510(k) clearance for the EZ-Injec LDV Sterile Safety Needle, a Low Dead Space Needle, Single Lumen, Hypodermic (Class II — Special Controls, product code QNS), submitted by Poonglim Pharmatech, Inc. (Gunsan, KR). The FDA issued a Cleared decision on February 16, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K210444 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2021
Decision Date February 16, 2021
Days to Decision —
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QNS — Low Dead Space Needle, Single Lumen, Hypodermic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570
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.