FDA 510(k)

Leonardo Duster

K号: K250504 · 2025-07-14

决定日期2025-07-14

产品代码GEX

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决定实质等同

器械摘要

Leonardo Duster is the device name listed in this FDA 510(k) record. The listed applicant is Ceramoptec GmbH. It received FDA 510(k) clearance on 2025-07-14 under 510(k) number K250504. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Leonardo Duster?

Leonardo Duster is a medical device that received FDA 510(k) clearance on 2025-07-14. The listed applicant is Ceramoptec GmbH. The 510(k) number is K250504.

When did Leonardo Duster receive FDA 510(k) clearance?

Leonardo Duster received FDA 510(k) clearance on 2025-07-14, under 510(k) number K250504.

Who is the listed applicant for Leonardo Duster?

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

What is the FDA product code for Leonardo Duster?

The FDA product code for Leonardo Duster is GEX. This falls under the Gastroenterology category.

列明Ceramoptec GmbH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。

K210951Leonardo Mini Blue

官方来源

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