REGENETEN™ 生物诱导植入物
K号: K242631 · 2024-11-26
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决定日期2024-11-26
产品代码OWY
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
REGENETEN™ Bioinductive Implant is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K242631. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the REGENETEN™ Bioinductive Implant?
REGENETEN™ Bioinductive Implant is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. The 510(k) number is K242631.
When did REGENETEN™ Bioinductive Implant receive FDA 510(k) clearance?
REGENETEN™ Bioinductive Implant received FDA 510(k) clearance on 2024-11-26, under 510(k) number K242631.
Who is the listed applicant for REGENETEN™ Bioinductive Implant?
The FDA 510(k) record lists Smith & Nephew Inc., Endoscopy Div. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for REGENETEN™ Bioinductive Implant?
The FDA product code for REGENETEN™ Bioinductive Implant is OWY.
相关临床试验
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相关器械（代码：OWY）
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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