OverStitch NXT 内窥镜缝合系统
K号: K231553 · 2023-06-29
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决定日期2023-06-29
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
OverStitch NXT Endoscopic Suturing System is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K231553. 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 OverStitch NXT Endoscopic Suturing System?
OverStitch NXT Endoscopic Suturing System is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Apollo Endosurgery, Inc.. The 510(k) number is K231553.
When did OverStitch NXT Endoscopic Suturing System receive FDA 510(k) clearance?
OverStitch NXT Endoscopic Suturing System received FDA 510(k) clearance on 2023-06-29, under 510(k) number K231553.
Who is the listed applicant for OverStitch NXT Endoscopic Suturing System?
The FDA 510(k) record lists Apollo Endosurgery, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OverStitch NXT Endoscopic Suturing System?
The FDA product code for OverStitch NXT Endoscopic Suturing System is OCW.
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Apollo Endosurgery, 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。
K252400Endomina EZFuse系统Endo Tools Therapeutics S.A.K243750SimpleStitch 缝合系统Envision EndoscopyK231240MaxTack® 电动固定装置CovidienK213271MedicloseTM 系统Health Value Creation B.V., Trading AS Corporis MedicalK211309endoMina系统Endo Tools Therapeutics S.A.K201744Su2ura Approximation DeviceAnchora Medical, Ltd.
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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