FDA 510(k)

Meniscus Versaflex

K号: K254188 · 2026-02-19

申请人GM Dos Reis Industria e Comercio Ltda.

决定日期2026-02-19

产品代码GAT

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决定实质等同

器械摘要

Meniscus Versaflex is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K254188. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Meniscus Versaflex?

Meniscus Versaflex is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K254188.

When did Meniscus Versaflex receive FDA 510(k) clearance?

Meniscus Versaflex received FDA 510(k) clearance on 2026-02-19, under 510(k) number K254188.

Who is the listed applicant for Meniscus Versaflex?

FDA 510(k)记录将GM Dos Reis Industria e Comercio Ltda.列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Meniscus Versaflex?

The FDA product code for Meniscus Versaflex is GAT.

列明GM Dos Reis Industria e Comercio Ltda.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。

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