胶原Dura再生膜 - 修复
K号: K251191 · 2025-11-18
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决定日期2025-11-18
产品代码GXQ
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Collagen Dura Regeneration Membrane - Repair is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K251191. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Collagen Dura Regeneration Membrane - Repair?
Collagen Dura Regeneration Membrane - Repair is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K251191.
When did Collagen Dura Regeneration Membrane - Repair receive FDA 510(k) clearance?
Collagen Dura Regeneration Membrane - Repair received FDA 510(k) clearance on 2025-11-18, under 510(k) number K251191.
Who is the listed applicant for Collagen Dura Regeneration Membrane - Repair?
The FDA 510(k) record lists Collagen Matrix, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Collagen Dura Regeneration Membrane - Repair?
The FDA product code for Collagen Dura Regeneration Membrane - Repair is GXQ.
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Collagen Matrix, 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：GXQ）
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。
K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura 生物贴LeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, Inc.K163456DuraGen Secure硬脑膜再生基质Integra LifeSciences Corporation
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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