FiXcision
K号: K182664 · 2018-12-07
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决定日期2018-12-07
产品代码KOA
咨询委员会GU
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决定实质等同
器械摘要
FiXcision is the device name listed in this FDA 510(k) record. The listed applicant is Agency For Medical Innovations GmbH. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K182664. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the FiXcision?
FiXcision is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Agency For Medical Innovations GmbH. The 510(k) number is K182664.
When did FiXcision receive FDA 510(k) clearance?
FiXcision received FDA 510(k) clearance on 2018-12-07, under 510(k) number K182664.
Who is the listed applicant for FiXcision?
The FDA 510(k) record lists Agency For Medical Innovations GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FiXcision?
The FDA product code for FiXcision is KOA.
相关临床试验
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列明Agency For Medical Innovations GmbH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。
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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