FDA.reportPublic FDA data

510(k) K213013

Device
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
Applicant
Jeil Tech Co., Ltd.
510(k) number
K213013
Product code
QNQ
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-19
Date received
2021-09-20
Regulation
880.5860
Classification name
Low Dead Space Piston Syringe
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chun-Gi Lee
Address
190, Maesilro, Sojeongmyeon Sejong-Si KR 54001 54001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QNQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety SyringeCMT Health PTE., Ltd.2026-02-19
K250127TSK SyringeTsk Laboratory, Japan2025-07-30
K250138Small Volume 0.2mL SyringeProsum Medical Limited2025-04-02
K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc.2024-11-20
K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.2024-05-31
K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc.2024-05-29
K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd2024-03-15
K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc.2023-09-15
K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd.2023-05-31
K220083LDV((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-05-25
K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc.2021-02-16