Cleared Traditional

PLPT LDV (Low Dead Volume) Sterile Syringe

K210443 · Poonglim Pharmatech, Inc. · General Hospital
Feb 2021
Decision
—
Days
Class 2
Risk

About This 510(k) Submission

K210443 is an FDA 510(k) clearance for the PLPT LDV (Low Dead Volume) Sterile Syringe, a Low Dead Space Piston Syringe (Class II — Special Controls, product code QNQ), 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 880.5860.

Submission Details

510(k) Number K210443 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 QNQ — Low Dead Space Piston Syringe
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860
Definition A Low Dead Space Syringe Is A Piston Syringe Designed To Reduce Medication Waste. The Device Consists Of A Calibrated Hollow Barrel, A Moveable Plunger, And May Include A Needle. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient.

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