Gynethotics® 阴道托
K号: K231786 · 2024-03-06
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申请人Cosm Medical
决定日期2024-03-06
产品代码HHW
咨询委员会OB
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决定实质等同
器械摘要
Gynethotics™ Pessary is the device name listed in this FDA 510(k) record. The listed applicant is Cosm Medical. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K231786. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Gynethotics™ Pessary?
Gynethotics™ Pessary is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Cosm Medical. The 510(k) number is K231786.
When did Gynethotics™ Pessary receive FDA 510(k) clearance?
Gynethotics™ Pessary received FDA 510(k) clearance on 2024-03-06, under 510(k) number K231786.
Who is the listed applicant for Gynethotics™ Pessary?
The FDA 510(k) record lists Cosm Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Gynethotics™ Pessary?
The FDA product code for Gynethotics™ Pessary is HHW.
相关临床试验
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相关器械（代码：HHW）
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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