HESTIA (L200-A)
K号: K242946 · 2025-10-03
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决定日期2025-10-03
产品代码GEX
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
HESTIA (L200-A) is the device name listed in this FDA 510(k) record. The listed applicant is Senbitec Co., Ltd.. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K242946. 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 HESTIA (L200-A)?
HESTIA (L200-A) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Senbitec Co., Ltd.. The 510(k) number is K242946.
When did HESTIA (L200-A) receive FDA 510(k) clearance?
HESTIA (L200-A) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K242946.
Who is the listed applicant for HESTIA (L200-A)?
The FDA 510(k) record lists Senbitec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HESTIA (L200-A)?
The FDA product code for HESTIA (L200-A) is GEX. This falls under the Gastroenterology category.
相关临床试验
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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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