MOLLI 2 系统
K号: K240042 · 2024-09-25
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决定日期2024-09-25
产品代码NEU
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
MOLLI 2 System is the device name listed in this FDA 510(k) record. The listed applicant is Molli Surgical, Inc.. It received FDA 510(k) clearance on 2024-09-25 under 510(k) number K240042. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MOLLI 2 System?
MOLLI 2 System is a medical device that received FDA 510(k) clearance on 2024-09-25. The listed applicant is Molli Surgical, Inc.. The 510(k) number is K240042.
When did MOLLI 2 System receive FDA 510(k) clearance?
MOLLI 2 System received FDA 510(k) clearance on 2024-09-25, under 510(k) number K240042.
Who is the listed applicant for MOLLI 2 System?
The FDA 510(k) record lists Molli Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MOLLI 2 System?
The FDA product code for MOLLI 2 System is NEU.
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Molli Surgical, 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：NEU）
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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