CystoSure Plus导管
K号: K181346 · 2018-08-06
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决定日期2018-08-06
产品代码EZL
咨询委员会GU
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决定实质等同
器械摘要
CystoSure Plus Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Emmy Medical, LLC. It received FDA 510(k) clearance on 2018-08-06 under 510(k) number K181346. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CystoSure Plus Catheter?
CystoSure Plus Catheter is a medical device that received FDA 510(k) clearance on 2018-08-06. The listed applicant is Emmy Medical, LLC. The 510(k) number is K181346.
When did CystoSure Plus Catheter receive FDA 510(k) clearance?
CystoSure Plus Catheter received FDA 510(k) clearance on 2018-08-06, under 510(k) number K181346.
Who is the listed applicant for CystoSure Plus Catheter?
The FDA 510(k) record lists Emmy Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CystoSure Plus Catheter?
The FDA product code for CystoSure Plus Catheter is EZL.
相关临床试验
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相关器械（代码：EZL）
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。
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官方来源
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