Amsel 内窥镜封堵器
K号: K180650 · 2018-11-15
广告
决定日期2018-11-15
产品代码FZP
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Amsel Endo Occluder is the device name listed in this FDA 510(k) record. The listed applicant is Amsel Medical Corporation. It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K180650. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Amsel Endo Occluder?
Amsel Endo Occluder is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Amsel Medical Corporation. The 510(k) number is K180650.
When did Amsel Endo Occluder receive FDA 510(k) clearance?
Amsel Endo Occluder received FDA 510(k) clearance on 2018-11-15, under 510(k) number K180650.
Who is the listed applicant for Amsel Endo Occluder?
The FDA 510(k) record lists Amsel Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Amsel Endo Occluder?
The FDA product code for Amsel Endo Occluder is FZP.
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：FZP）
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。
K260677血管闭合装置（VCD177213P）Vcd Medical S.R.L.K254231Inno-Hook™ 一次性夹子应用器（结扎夹）和 Inno-Hook™ 结扎夹Taiwan Surgical CorporationK253781InnoClip 套管夹应用器Taiwan Surgical CorporationK253903InnoClip 一次性套管夹应用器Taiwan Surgical CorporationK250643一次性聚合物结扎夹Hangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical
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