LapBox 组织隔离去除系统
K号: K221365 · 2022-08-25
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决定日期2022-08-25
产品代码GCJ
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
LapBox Tissue Containment Removal System is the device name listed in this FDA 510(k) record. The listed applicant is Ark Surgical, Ltd.. It received FDA 510(k) clearance on 2022-08-25 under 510(k) number K221365. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LapBox Tissue Containment Removal System?
LapBox Tissue Containment Removal System is a medical device that received FDA 510(k) clearance on 2022-08-25. The listed applicant is Ark Surgical, Ltd.. The 510(k) number is K221365.
When did LapBox Tissue Containment Removal System receive FDA 510(k) clearance?
LapBox Tissue Containment Removal System received FDA 510(k) clearance on 2022-08-25, under 510(k) number K221365.
Who is the listed applicant for LapBox Tissue Containment Removal System?
The FDA 510(k) record lists Ark Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LapBox Tissue Containment Removal System?
The FDA product code for LapBox Tissue Containment Removal System is GCJ.
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：GCJ）
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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