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FDA 510(k)

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))

K-Number: K231856 · 2024-03-15

ApplicantMedexel Co.,Ltd
Decision Date2024-03-15
Product CodeQNQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is a medical device manufactured by Medexel Co.,Ltd. It received FDA 510(k) clearance on 2024-03-15 under approval number K231856. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Medexel Co.,Ltd. The 510(k) number is K231856.

When was TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) approved by the FDA?

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) received FDA 510(k) clearance on 2024-03-15, under approval number K231856.

What company makes TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is manufactured by Medexel Co.,Ltd.

What is the FDA product code for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

The FDA product code for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is QNQ.

Related Clinical Trials

NCT02603640 " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy COMPLETED NCT07534072 Efficacy of Skeletally Anchored Modified Leaf Expander in Maxillary Molar Distalization COMPLETED

Related PubMed Literature

PMID: 37496031 Adapting modeling and simulation credibility standards to computational systems biology. Journal of translational medicine (2023)

Other Devices by Medexel Co.,Ltd

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Related Devices (Code: QNQ)

K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. K213013Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeJeil Tech Co., Ltd. K220083LDV((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc. K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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