Gabriel 3路EnFit阀
K号: K201741 · 2020-11-05
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决定日期2020-11-05
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
Gabriel 3 Way EnFit Valve is the device name listed in this FDA 510(k) record. The listed applicant is Syncro Medical Innovations, Inc.. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K201741. 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 Gabriel 3 Way EnFit Valve?
Gabriel 3 Way EnFit Valve is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Syncro Medical Innovations, Inc.. The 510(k) number is K201741.
When did Gabriel 3 Way EnFit Valve receive FDA 510(k) clearance?
Gabriel 3 Way EnFit Valve received FDA 510(k) clearance on 2020-11-05, under 510(k) number K201741.
Who is the listed applicant for Gabriel 3 Way EnFit Valve?
The FDA 510(k) record lists Syncro Medical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Gabriel 3 Way EnFit Valve?
The FDA product code for Gabriel 3 Way EnFit Valve 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。
列明Syncro Medical Innovations, Inc.为申报人的其他记录
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.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.
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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