输尿管扩张器套装，输尿管扩张器
K号: K173654 · 2018-07-17
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决定日期2018-07-17
产品代码EZN
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
Ureteral Dilator Sets, Ureteral Dilators is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-07-17 under 510(k) number K173654. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ureteral Dilator Sets, Ureteral Dilators?
Ureteral Dilator Sets, Ureteral Dilators is a medical device that received FDA 510(k) clearance on 2018-07-17. The listed applicant is Cook Incorporated. The 510(k) number is K173654.
When did Ureteral Dilator Sets, Ureteral Dilators receive FDA 510(k) clearance?
Ureteral Dilator Sets, Ureteral Dilators received FDA 510(k) clearance on 2018-07-17, under 510(k) number K173654.
Who is the listed applicant for Ureteral Dilator Sets, Ureteral Dilators?
The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ureteral Dilator Sets, Ureteral Dilators?
The FDA product code for Ureteral Dilator Sets, Ureteral Dilators is EZN.
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Cook Incorporated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：EZN）
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。
K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA 肾盂输尿管扩张器套装，ARMADA 诺丁汉一步扩张器，ARMADA Amplatz 肾脏扩张器套装，ARMADA 肾脏扩张器，Glider Amplatz 套管，ARMADA 肾脏扩张器带Amplatz套管，筋膜扩张器套装，导引套管，导引导管Allwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX 气球扩张导管Dornier Medtech America, Inc.K180756安全导丝引导器Cook IncorporatedK180028Cook 810 Set, Desilets-Hoffman 引导器套装Cook Incorporated
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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