CuRAS 混合型
K号: K253123 · 2025-11-20
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器械摘要
CuRAS hybrid is the device name listed in this FDA 510(k) record. The listed applicant is Classys, Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K253123. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the CuRAS hybrid?
CuRAS hybrid is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Classys, Inc.. The 510(k) number is K253123.
When did CuRAS hybrid receive FDA 510(k) clearance?
CuRAS hybrid received FDA 510(k) clearance on 2025-11-20, under 510(k) number K253123.
Who is the listed applicant for CuRAS hybrid?
The FDA 510(k) record lists Classys, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CuRAS hybrid?
The FDA product code for CuRAS hybrid is GEX. This falls under the Gastroenterology category.
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Classys, 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：GEX）
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。
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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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