FDA 510(k)

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

Número K: K231856 · 2024-03-15

Data da decisão2024-03-15

Código do produtoQNQ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Medexel Co.,Ltd. The 510(k) number is K231856.

When did TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) receive FDA 510(k) clearance?

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

Who is the listed applicant for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

The FDA 510(k) record lists Medexel Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

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.

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Dispositivos Relacionados (Código: QNQ)

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.K250127TSK SyringeTsk Laboratory, Japan K250138Small Volume 0.2mL SyringeProsum Medical Limited 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.K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc.

Fonte oficial

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