FDA 510(k)

Endofill

K号: K231387 · 2023-07-10

决定日期2023-07-10

产品代码KIF

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决定实质等同

器械摘要

Endofill is the device name listed in this FDA 510(k) record. The listed applicant is Lumendo AG. It received FDA 510(k) clearance on 2023-07-10 under 510(k) number K231387. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endofill?

Endofill is a medical device that received FDA 510(k) clearance on 2023-07-10. The listed applicant is Lumendo AG. The 510(k) number is K231387.

When did Endofill receive FDA 510(k) clearance?

Endofill received FDA 510(k) clearance on 2023-07-10, under 510(k) number K231387.

Who is the listed applicant for Endofill?

The FDA 510(k) record lists Lumendo AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endofill?

The FDA product code for Endofill is KIF.

列明Lumendo AG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。

K232076Fibercure

官方来源

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