一次性内窥镜阀门套装
K号: K250732 · 2025-06-20
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决定日期2025-06-20
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
Disposable Endoscopy Valve Set is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K250732. 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 Disposable Endoscopy Valve Set?
Disposable Endoscopy Valve Set is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K250732.
When did Disposable Endoscopy Valve Set receive FDA 510(k) clearance?
Disposable Endoscopy Valve Set received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250732.
Who is the listed applicant for Disposable Endoscopy Valve Set?
FDA 510(k)记录将扬州法尔莱医疗器械科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Disposable Endoscopy Valve Set?
The FDA product code for Disposable Endoscopy Valve Set 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。
列明Yangzhou Fartley Medical Instrument Technology Co., Ltd.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：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 CorporationK241842Luer-Split MAJ-2092Olympus Medical Systems CorporationK250140Defendo Fujifilm 700 单次使用清洁适配器Steris Corparation
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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