FDA 510(k)

Saffron 固定系统

K号: K220420 · 2022-06-10

决定日期2022-06-10

产品代码PBQ

咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Saffron Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K220420. The device is classified under product code PBQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Saffron Fixation System?

Saffron Fixation System is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Coloplast A/S. The 510(k) number is K220420.

When did Saffron Fixation System receive FDA 510(k) clearance?

Saffron Fixation System received FDA 510(k) clearance on 2022-06-10, under 510(k) number K220420.

Who is the listed applicant for Saffron Fixation System?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Saffron Fixation System?

The FDA product code for Saffron Fixation System is PBQ.

列明Coloplast A/S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。

K262045Luja软性产品 K221874Altis单切口悬吊系统 K191536Biatain 硅胶银 K181811ReTrace 肾盂输尿管通道鞘 K173527Digitex Delivery Device

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。