FDA 510(k)

一次性針導引器及網格

K 號：K223689 · 2023-08-02

決定日期2023-08-02

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Advance Medical Designs, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K163050Advance Medical Designs, Inc. 無菌超聲波膠

相關器械（代碼：ITX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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