FDA 510(k)

VereSee光学Veres针和内镜摄像头

K号: K252640 · 2025-10-20

决定日期2025-10-20

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

VereSee Optical Veres Needle and Endoscopic Camera is the device name listed in this FDA 510(k) record. The listed applicant is Freyja Healthcare, LLC. It received FDA 510(k) clearance on 2025-10-20 under 510(k) number K252640. 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 VereSee Optical Veres Needle and Endoscopic Camera?

VereSee Optical Veres Needle and Endoscopic Camera is a medical device that received FDA 510(k) clearance on 2025-10-20. The listed applicant is Freyja Healthcare, LLC. The 510(k) number is K252640.

When did VereSee Optical Veres Needle and Endoscopic Camera receive FDA 510(k) clearance?

VereSee Optical Veres Needle and Endoscopic Camera received FDA 510(k) clearance on 2025-10-20, under 510(k) number K252640.

Who is the listed applicant for VereSee Optical Veres Needle and Endoscopic Camera?

FDA 510(k)记录中列出Freyja Healthcare, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for VereSee Optical Veres Needle and Endoscopic Camera?

The FDA product code for VereSee Optical Veres Needle and Endoscopic Camera is GCJ.

列明Freyja Healthcare, LLC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。

K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）K232464VereSee 光学 Veres 针系统

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

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