FDA 510(k)

可视化接入与输送导管；PB数字控制器

K号: K252492 · 2026-04-24

决定日期2026-04-24

产品代码SHU

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

Visualized Access and Delivery Catheter; PB Digital Controller is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K252492. The device is classified under product code SHU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Visualized Access and Delivery Catheter; PB Digital Controller?

Visualized Access and Delivery Catheter; PB Digital Controller is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K252492.

When did Visualized Access and Delivery Catheter; PB Digital Controller receive FDA 510(k) clearance?

Visualized Access and Delivery Catheter; PB Digital Controller received FDA 510(k) clearance on 2026-04-24, under 510(k) number K252492.

Who is the listed applicant for Visualized Access and Delivery Catheter; PB Digital Controller?

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

What is the FDA product code for Visualized Access and Delivery Catheter; PB Digital Controller?

The FDA product code for Visualized Access and Delivery Catheter; PB Digital Controller is SHU.

列明Micro-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。

K251692高级组织切除设备 K250229双重作用组织闭合装置 K243388一次性远端帽 K243471提取篮 K230127胆道塑料支架，胆道塑料支架导引器，胆道塑料支架套装，胆道塑料支架导引器/短导丝兼容型，胆道塑料支架套装/短导丝兼容型 K221784一次性视频胰胆管镜，PB数字控制器

查看所有 37 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

相关临床试验

列明Micro-Tech (Nanjing) Co., Ltd.为申报人的其他记录

官方来源