Cleared Traditional

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

K221860 · Poonglim Pharmatech, Inc. · General Hospital

Sep 2023

Decision

445d

Days

Class 2

Risk

About This 510(k) Submission

K221860 is an FDA 510(k) clearance for the PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) 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 September 15, 2023, 445 days after receiving the submission on June 27, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K221860 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2022
Decision Date	September 15, 2023
Days to Decision	445 days
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.