XEN 青光眼治疗系统
K号: K161457 · 2016-11-21
广告
决定日期2016-11-21
产品代码KYF
咨询委员会OP
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
XEN Glaucoma Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Allergan, Inc.. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K161457. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the XEN Glaucoma Treatment System?
XEN Glaucoma Treatment System is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Allergan, Inc.. The 510(k) number is K161457.
When did XEN Glaucoma Treatment System receive FDA 510(k) clearance?
XEN Glaucoma Treatment System received FDA 510(k) clearance on 2016-11-21, under 510(k) number K161457.
Who is the listed applicant for XEN Glaucoma Treatment System?
The FDA 510(k) record lists Allergan, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XEN Glaucoma Treatment System?
The FDA product code for XEN Glaucoma Treatment System is KYF.
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Allergan, Inc.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：KYF）
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。
K231051Ahmed® 慢性青光眼阀门型号 FP8New World Medical, Inc.K230975Ahmed® 慢性青光眼阀门型号 FP7New World Medical, Inc.K220032iStent无限 trabecular 微循环系统，型号 iS3Glaukos CorporationK182518AHMED ClearPath青光眼引流装置New World Medical, Inc.K171451Ahmed 慢性青光眼阀门型号 FP8New World Medical, Inc.K162060Ahmed 慢性青光眼阀门New World Medical, Inc.
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。
广告