FDA 510(k)

LiNA CystoVu® HD (CYV-100-5; CYV-101-5); LiNA ScopeVu® (SCP-100-1)

K号: K240227 · 2024-08-22

决定日期2024-08-22

产品代码FAJ

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决定实质等同

器械摘要

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K240227. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)?

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Lina Medical Aps. The 510(k) number is K240227.

When did LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) receive FDA 510(k) clearance?

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) received FDA 510(k) clearance on 2024-08-22, under 510(k) number K240227.

Who is the listed applicant for LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)?

The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)?

The FDA product code for LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) is FAJ.

列明Lina Medical Aps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。

K223932SafeAir combi（SFR-combi-US）K221085LiNA OperaScope 针 K193007LiNA OperaScope带HDMI线和机载LCD - 6台，LiNA OperaScope录制模块 K182224SafeAir烟雾抽吸器紧凑型 K182354SafeAir伸缩烟雾笔 K171113LiNA OperaScope带HDMI线和机载LCD-单台，LiNA OperaScope带HDMI线和机载LCD-6台，LiNA OperaScope录制模块

查看所有 7 个设备 →

相关器械（代码：FAJ）

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

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