FDA 510(k)

一次性远端端头胶带罩

K号: K252457 · 2026-01-30

申请人Shanghai SeeGen Photoelectric Technology Co., Ltd.

决定日期2026-01-30

产品代码FDF

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

Disposable Distal End Tape Hood is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K252457. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Distal End Tape Hood?

Disposable Distal End Tape Hood is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K252457.

When did Disposable Distal End Tape Hood receive FDA 510(k) clearance?

Disposable Distal End Tape Hood received FDA 510(k) clearance on 2026-01-30, under 510(k) number K252457.

Who is the listed applicant for Disposable Distal End Tape Hood?

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

What is the FDA product code for Disposable Distal End Tape Hood?

The FDA product code for Disposable Distal End Tape Hood is FDF.

列明Shanghai SeeGen Photoelectric 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。

K243535柔性视频胆道镜（CHV-110J-U）；柔性视频胆道镜（CHV-US120J-U）K241532柔性视频胆道-膀胱-尿道镜系统（PL-2100）K222499一次性内镜阀门组件套件 K222261柔性视频胆道镜系统 K211686柔性视频胆道-膀胱-尿道镜系统

官方来源

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