Niti-S 胆道速 D 支架
K号: K223626 · 2023-05-26
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决定日期2023-05-26
产品代码FGE
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Unknown
器械摘要
Niti-S Biliary Speed D Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K223626. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.
常见问题
What is the Niti-S Biliary Speed D Stent?
Niti-S Biliary Speed D Stent is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K223626.
When did Niti-S Biliary Speed D Stent receive FDA 510(k) clearance?
Niti-S Biliary Speed D Stent received FDA 510(k) clearance on 2023-05-26, under 510(k) number K223626.
Who is the listed applicant for Niti-S Biliary Speed D Stent?
The FDA 510(k) record lists Taewoong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Niti-S Biliary Speed D Stent?
The FDA product code for Niti-S Biliary Speed D Stent is FGE.
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列明Taewoong Medical Co., Ltd.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：FGE）
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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