Advincula Delineator 宫腔操纵器
K号: K180429 · 2018-03-14
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决定日期2018-03-14
产品代码HEW
咨询委员会OB
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器械摘要
Advincula Delineator Uterine Manipulator is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2018-03-14 under 510(k) number K180429. The device is classified under product code HEW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Advincula Delineator Uterine Manipulator?
Advincula Delineator Uterine Manipulator is a medical device that received FDA 510(k) clearance on 2018-03-14. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K180429.
When did Advincula Delineator Uterine Manipulator receive FDA 510(k) clearance?
Advincula Delineator Uterine Manipulator received FDA 510(k) clearance on 2018-03-14, under 510(k) number K180429.
Who is the listed applicant for Advincula Delineator Uterine Manipulator?
FDA 510(k)记录中列出CooperSurgical, Inc.为申请人。这本身并不足以确立设备制造商。
What is the FDA product code for Advincula Delineator Uterine Manipulator?
The FDA product code for Advincula Delineator Uterine Manipulator is HEW.
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CooperSurgical, 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：HEW）
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。
K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceApplied Medical Resources Corp.K201086Advincula Delineator 宫腔操纵器CooperSurgical, Inc.K191294经阴道入路平台Applied Medical Resources Corp.K161065ColpoWave® Colpotomizer and CerviGrip® Uterine ManipulatorSurgitools Pty , 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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