FDA 510(k)

一次性针引导器和网格

K号: K223689 · 2023-08-02

决定日期2023-08-02

产品代码ITX

咨询委员会RA

决定实质等同

器械摘要

Disposable Needle Guides and Grids is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 2023-08-02 under 510(k) number K223689. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Needle Guides and Grids?

Disposable Needle Guides and Grids is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K223689.

When did Disposable Needle Guides and Grids receive FDA 510(k) clearance?

Disposable Needle Guides and Grids received FDA 510(k) clearance on 2023-08-02, under 510(k) number K223689.

Who is the listed applicant for Disposable Needle Guides and Grids?

The FDA 510(k) record lists Advance Medical Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Needle Guides and Grids?

The FDA product code for Disposable Needle Guides and Grids is ITX.

列明Advance Medical Designs, Inc.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。

K163050Advance Medical Designs, Inc.无菌超声凝胶

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。