AbClose - 端口部位闭合装置
K号: K160117 · 2016-09-09
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决定日期2016-09-09
产品代码OCW
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
AbClose - Port Site Closure Device is the device name listed in this FDA 510(k) record. The listed applicant is Medeon Biodesign, Inc.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K160117. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AbClose - Port Site Closure Device?
AbClose - Port Site Closure Device is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Medeon Biodesign, Inc.. The 510(k) number is K160117.
When did AbClose - Port Site Closure Device receive FDA 510(k) clearance?
AbClose - Port Site Closure Device received FDA 510(k) clearance on 2016-09-09, under 510(k) number K160117.
Who is the listed applicant for AbClose - Port Site Closure Device?
The FDA 510(k) record lists Medeon Biodesign, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AbClose - Port Site Closure Device?
The FDA product code for AbClose - Port Site Closure Device is OCW.
相关临床试验
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列明Medeon Biodesign, 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：OCW）
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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