FDA 510(k)

胆胰管内窥镜系统

K号: K241444 · 2025-01-21

申请人Shenzhen HugeMed Medical Technical Development Co., Ltd.

决定日期2025-01-21

产品代码FBN

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

Biliary Pancreaticobiliary Scope System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2025-01-21 under 510(k) number K241444. 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 Biliary Pancreaticobiliary Scope System?

Biliary Pancreaticobiliary Scope System is a medical device that received FDA 510(k) clearance on 2025-01-21. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K241444.

When did Biliary Pancreaticobiliary Scope System receive FDA 510(k) clearance?

Biliary Pancreaticobiliary Scope System received FDA 510(k) clearance on 2025-01-21, under 510(k) number K241444.

Who is the listed applicant for Biliary Pancreaticobiliary Scope System?

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

What is the FDA product code for Biliary Pancreaticobiliary Scope System?

The FDA product code for Biliary Pancreaticobiliary Scope System is FBN.