FDA 510(k)

一次性远端帽

K号: K253139 · 2026-03-19

决定日期2026-03-19

产品代码FBN

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决定实质等同

器械摘要

Disposable Distal Cap is the device name listed in this FDA 510(k) record. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K253139. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Distal Cap?

Disposable Distal Cap is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K253139.

When did Disposable Distal Cap receive FDA 510(k) clearance?

Disposable Distal Cap received FDA 510(k) clearance on 2026-03-19, under 510(k) number K253139.

Who is the listed applicant for Disposable Distal Cap?

The FDA 510(k) record lists Mirco-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Distal Cap?

The FDA product code for Disposable Distal Cap is FBN.

列明Mirco-Tech (Nanjing) 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。

K260262注射针 K253832扩张球囊导管 K254153一次性视频内镜；PB数字控制器 K233772一次性双作用组织闭合装置

相关器械（代码：FBN）

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。

K254153一次性视频内镜；PB数字控制器Mirco-Tech (Nanjing) Co., Ltd.K251338胆管镜可视化系统（一次性视频胆管镜：SCV-P-01G，SCV-P-02G；全高清可视化内镜图像处理器：HDVS-S300A，HDVS-S300B，HDVS-S300C，HDVS-S300D）Scivita Medical Technology Co., Ltd.K251170Tangent 单次使用数字系统：Tangent 单次使用数字导管和 Tangent 数字控制器Tangent Endoscopy, LLC K243535柔性视频胆道镜（CHV-110J-U）；柔性视频胆道镜（CHV-US120J-U）Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444胆胰管内窥镜系统Shenzhen HugeMed Medical Technical Development Co., Ltd.K233752Dragonfly® 胰胆镜；Dragonfly® 数字控制器；Dragonfly® 工具通道盖CenterPoint Systems, LLC

官方来源

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