FDA 510(k)

Cysto-Gastro-Sets

K号: K211909 · 2022-06-09

决定日期2022-06-09

产品代码KNS

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决定实质等同

器械摘要

Cysto-Gastro-Sets is the device name listed in this FDA 510(k) record. The listed applicant is G-Flex Europe Sprl. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K211909. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cysto-Gastro-Sets?

Cysto-Gastro-Sets is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is G-Flex Europe Sprl. The 510(k) number is K211909.

When did Cysto-Gastro-Sets receive FDA 510(k) clearance?

Cysto-Gastro-Sets received FDA 510(k) clearance on 2022-06-09, under 510(k) number K211909.

Who is the listed applicant for Cysto-Gastro-Sets?

The FDA 510(k) record lists G-Flex Europe Sprl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cysto-Gastro-Sets?

The FDA product code for Cysto-Gastro-Sets is KNS.

列明G-Flex Europe Sprl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。

K222006硬化疗法与内窥镜针

相关器械（代码：KNS）

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。

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