FDA 510(k)

Altis单切口悬吊系统

K号: K221874 · 2023-02-15

决定日期2023-02-15

产品代码PAH

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决定实质等同

器械摘要

Altis Single Incision Sling 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 2023-02-15 under 510(k) number K221874. The device is classified under product code PAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Altis Single Incision Sling System?

Altis Single Incision Sling System is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Coloplast A/S. The 510(k) number is K221874.

When did Altis Single Incision Sling System receive FDA 510(k) clearance?

Altis Single Incision Sling System received FDA 510(k) clearance on 2023-02-15, under 510(k) number K221874.

Who is the listed applicant for Altis Single Incision Sling 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 Altis Single Incision Sling System?

The FDA product code for Altis Single Incision Sling System is PAH.

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 K220420Saffron 固定系统 K191536Biatain 硅胶银 K181811ReTrace 肾盂输尿管通道鞘 K173527Digitex Delivery Device

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