FDA 510(k)

4K内窥镜摄像机系统（SV-800, SV-800I, SV-800R, SV-800N）

K号: K250551 · 2025-10-02

申请人Shenzhen Sophway Technology Co., Ltd.

决定日期2025-10-02

产品代码GCJ

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决定实质等同

器械摘要

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sophway Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-02 under 510(k) number K250551. 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 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is Shenzhen Sophway Technology Co., Ltd.. The 510(k) number is K250551.

When did 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) receive FDA 510(k) clearance?

4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) received FDA 510(k) clearance on 2025-10-02, under 510(k) number K250551.

Who is the listed applicant for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

The FDA 510(k) record lists Shenzhen Sophway Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)?

The FDA product code for 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) is GCJ.

列明Shenzhen Sophway Technology Co., Ltd.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。

K250204内窥镜摄像头系统

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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