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FDA 510(k)

肠内引流系统，肠内药物吸管

K号: K242917 · 2025-06-18

申请人HMC Premedical S.p.A.
决定日期2025-06-18
产品代码PIF
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Enteral Drainage System, Enteral Medicine straw is the device name listed in this FDA 510(k) record. The listed applicant is HMC Premedical S.p.A.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K242917. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Enteral Drainage System, Enteral Medicine straw?

Enteral Drainage System, Enteral Medicine straw is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is HMC Premedical S.p.A.. The 510(k) number is K242917.

When did Enteral Drainage System, Enteral Medicine straw receive FDA 510(k) clearance?

Enteral Drainage System, Enteral Medicine straw received FDA 510(k) clearance on 2025-06-18, under 510(k) number K242917.

Who is the listed applicant for Enteral Drainage System, Enteral Medicine straw?

The FDA 510(k) record lists HMC Premedical S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enteral Drainage System, Enteral Medicine straw?

The FDA product code for Enteral Drainage System, Enteral Medicine straw is PIF.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：PIF）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260110丹诺美德胃造口按钮延长套件Danumed Medizintechnik GmbHK253715Edi 导管 ENFit 6Fr/48 cm (6893166)；Edi 导管 ENFit 6Fr/49cm (6893273)；Edi 导管 ENFit 6Fr/50cm (6893274)；Edi 导管 ENFit 8Fr/50cm (6893275)；Edi 导管 ENFit 8Fr/100cm (6893276)；Edi 导管 ENFit 8Fr/125cm (6893277)；Edi 导管 ENFit 12Fr/125cm (6893278)；Edi 导管 ENFit 16Fr/125cm (6893279)Maquet Critical Care ABK254170经皮内镜胃造瘘术（PEG）套件Degania Silicone , Ltd.K250481带ENFit®连接器的扩展输注套装SKY Medical, a.s.K240052一次性肠内营养喂养套装Beijing L&Z Medical Technology Development Co., Ltd.K233034电动+肠内营养系统OTCRockfield Medical

官方来源

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