带ENFit®连接器的扩展输注套装
K号: K250481 · 2025-04-18
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决定日期2025-04-18
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
Extension Feeding Set with ENFit™ Connectors is the device name listed in this FDA 510(k) record. The listed applicant is SKY Medical, a.s.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K250481. 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 Extension Feeding Set with ENFit™ Connectors?
Extension Feeding Set with ENFit™ Connectors is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is SKY Medical, a.s.. The 510(k) number is K250481.
When did Extension Feeding Set with ENFit™ Connectors receive FDA 510(k) clearance?
Extension Feeding Set with ENFit™ Connectors received FDA 510(k) clearance on 2025-04-18, under 510(k) number K250481.
Who is the listed applicant for Extension Feeding Set with ENFit™ Connectors?
The FDA 510(k) record lists SKY Medical, a.s. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Extension Feeding Set with ENFit™ Connectors?
The FDA product code for Extension Feeding Set with ENFit™ Connectors 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。
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.K242917肠内引流系统，肠内药物吸管HMC Premedical S.p.A.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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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