ARISTE AB 网状物
K号: K211132 · 2022-03-18
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决定日期2022-03-18
产品代码FTL
咨询委员会SU
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决定实质等同
器械摘要
ARISTE AB Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Ariste Medical, LLC. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K211132. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ARISTE AB Mesh?
ARISTE AB Mesh is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Ariste Medical, LLC. The 510(k) number is K211132.
When did ARISTE AB Mesh receive FDA 510(k) clearance?
ARISTE AB Mesh received FDA 510(k) clearance on 2022-03-18, under 510(k) number K211132.
Who is the listed applicant for ARISTE AB Mesh?
The FDA 510(k) record lists Ariste Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ARISTE AB Mesh?
The FDA product code for ARISTE AB Mesh is FTL.
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。
相关器械（代码：FTL）
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
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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