Revolve外科手术系统
K号: K243968 · 2025-10-03
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决定日期2025-10-03
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
Revolve Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Revolve Surgical, Inc.. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K243968. 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 Revolve Surgical System?
Revolve Surgical System is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Revolve Surgical, Inc.. The 510(k) number is K243968.
When did Revolve Surgical System receive FDA 510(k) clearance?
Revolve Surgical System received FDA 510(k) clearance on 2025-10-03, under 510(k) number K243968.
Who is the listed applicant for Revolve Surgical System?
The FDA 510(k) record lists Revolve Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Revolve Surgical System?
The FDA product code for Revolve Surgical 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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