FDA 510(k)

PAL灭菌盒

K号: K243589 · 2025-06-20

决定日期2025-06-20

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

PAL Sterilization Case is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K243589. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PAL Sterilization Case?

PAL Sterilization Case is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Microaire Surgical Instruments, LLC. The 510(k) number is K243589.

When did PAL Sterilization Case receive FDA 510(k) clearance?

PAL Sterilization Case received FDA 510(k) clearance on 2025-06-20, under 510(k) number K243589.

Who is the listed applicant for PAL Sterilization Case?

The FDA 510(k) record lists Microaire Surgical Instruments, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAL Sterilization Case?

The FDA product code for PAL Sterilization Case is KCT.

列明Microaire Surgical Instruments, LLC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。

K244026PAL 7020控制台 K242804PAL吸引系统 K220318PAL浸润系统 K212024PAL系统 K181819SMARTRELEASE 内窥镜软组织释放系统 K171286PAL多用途导管和PAL手动棒

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官方来源

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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。