FDA 510(k)

LiNA OperaScope 针

K号: K221085 · 2022-09-02

决定日期2022-09-02

产品代码FBK

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决定实质等同

器械摘要

LiNA OperaScope Needle 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 2022-09-02 under 510(k) number K221085. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LiNA OperaScope Needle?

LiNA OperaScope Needle is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Lina Medical Aps. The 510(k) number is K221085.

When did LiNA OperaScope Needle receive FDA 510(k) clearance?

LiNA OperaScope Needle received FDA 510(k) clearance on 2022-09-02, under 510(k) number K221085.

Who is the listed applicant for LiNA OperaScope Needle?

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 OperaScope Needle?

The FDA product code for LiNA OperaScope Needle is FBK.

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。

K240227LiNA CystoVu® HD (CYV-100-5; CYV-101-5); LiNA ScopeVu® (SCP-100-1)K223932SafeAir combi（SFR-combi-US）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：FBK）

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。

官方来源

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