FDA 510(k) Applications for Medical Device Product Code "QNQ"

FDA 510(k) Number Applicant Device Name Decision Date
K220083 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. LDV((Low Dead Volume )Syringe 05/25/2022
K213010 Feeltech Co., Ltd. FEELject LDV (Low dead volume) syringe 05/31/2023
K213013 Jeil Tech Co., Ltd. Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe 09/19/2022
K231856 MedExel Co., Ltd. TopFine« LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) 03/15/2024
K210443 Poonglim Pharmatech Inc. PLPT LDV (Low Dead Volume) Sterile Syringe 02/16/2021
K221860 Poonglim Pharmatech Inc. PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe 09/15/2023
K241190 Poonglim Pharmatech Inc. PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe 05/29/2024
K250138 Prosum Medical Limited Small Volume 0.2mL Syringe 04/02/2025
K232943 Smiths Medical ASD Inc Hypodermic Needle-Pro« EDGEÖ Safety Device with Low Dead Space Syringe 05/31/2024
K242291 Sol-Millennium Medical Inc. SOL-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 (L 11/20/2024


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