自动微针系统（CODE-X）
K号: K252591 · 2026-05-13
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决定日期2026-05-13
产品代码QAI
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
Automatic Micro Needle System (CODE-X) is the device name listed in this FDA 510(k) record. The listed applicant is Woorhi Mechatronics Co., Ltd.. It received FDA 510(k) clearance on 2026-05-13 under 510(k) number K252591. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Automatic Micro Needle System (CODE-X)?
Automatic Micro Needle System (CODE-X) is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is Woorhi Mechatronics Co., Ltd.. The 510(k) number is K252591.
When did Automatic Micro Needle System (CODE-X) receive FDA 510(k) clearance?
Automatic Micro Needle System (CODE-X) received FDA 510(k) clearance on 2026-05-13, under 510(k) number K252591.
Who is the listed applicant for Automatic Micro Needle System (CODE-X)?
The FDA 510(k) record lists Woorhi Mechatronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Automatic Micro Needle System (CODE-X)?
The FDA product code for Automatic Micro Needle System (CODE-X) is QAI.
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。
相关器械（代码：QAI）
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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