FDA 510(k)

Small Volume 0.2mL Syringe

Номер K: K250138 · 2025-04-02

Дата решения2025-04-02

Код продуктаQNQ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Small Volume 0.2mL Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Prosum Medical Limited. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K250138. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Small Volume 0.2mL Syringe?

Small Volume 0.2mL Syringe is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Prosum Medical Limited. The 510(k) number is K250138.

When did Small Volume 0.2mL Syringe receive FDA 510(k) clearance?

Small Volume 0.2mL Syringe received FDA 510(k) clearance on 2025-04-02, under 510(k) number K250138.

Who is the listed applicant for Small Volume 0.2mL Syringe?

The FDA 510(k) record lists Prosum Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Small Volume 0.2mL Syringe?

The FDA product code for Small Volume 0.2mL Syringe is QNQ.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: 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 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.K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd

Официальный источник

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