ColpoWave® Colpotomizer and CerviGrip® Uterine Manipulator
K号: K161065 · 2016-10-27
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决定日期2016-10-27
产品代码HEW
咨询委员会OB
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器械摘要
ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator is the device name listed in this FDA 510(k) record. The listed applicant is Surgitools Pty , Ltd.. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K161065. 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 ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator?
ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Surgitools Pty , Ltd.. The 510(k) number is K161065.
When did ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator receive FDA 510(k) clearance?
ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator received FDA 510(k) clearance on 2016-10-27, under 510(k) number K161065.
Who is the listed applicant for ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator?
The FDA 510(k) record lists Surgitools Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator?
The FDA product code for ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator is HEW.
相关临床试验
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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。
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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