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FDA 510(k)

Defendo Fujifilm 700 单次使用活检阀；Defendo Fujifilm 700 单次使用空气/水阀；Defendo Fujifilm 700 单次使用吸引阀；ENDOGATOR Fujifilm 700 单次使用连接器；Defendo Fujifilm 700 单次使用清洁适配器

K号: K232329 · 2023-12-21

申请人Medivators (A Subsidiary of Steris Corporation)
决定日期2023-12-21
产品代码ODC
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

Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Medivators (A Subsidiary of Steris Corporation). It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K232329. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter?

Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Medivators (A Subsidiary of Steris Corporation). The 510(k) number is K232329.

When did Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter receive FDA 510(k) clearance?

Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter received FDA 510(k) clearance on 2023-12-21, under 510(k) number K232329.

Who is the listed applicant for Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter?

The FDA 510(k) record lists Medivators (A Subsidiary of Steris Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter?

The FDA product code for Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter is ODC.

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

列明Medivators (A Subsidiary of Steris Corporation)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。

K232067Defendo Fujifilm 500/600 单次使用空气/水阀，Defendo Fujifilm 500/600 单次使用吸引阀，Defendo Fujifilm 500/600 单次使用活检阀，Endogator Fujifilm 500/600 单次使用连接器K232004Defendo Pentax 单次使用活检阀，Defendo Pentax 单次使用空气/水阀，Defendo Pentax 单次使用吸引阀，Endogator Pentax 单次使用连接器

相关器械（代码：ODC）

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。

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca 空气/水及吸阀Boston ScientificK250949吸水阀（MAJ-1443）；空气/水阀（MAJ-1444）Olympus Medical Systems CorporationK250732一次性内窥镜阀门套装Yangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

官方来源

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