FDA 510(k)

Gentrix外科馬特拉克斯，Gentrix外科馬特拉克斯高位

K 號：K182259 · 2019-02-07

決定日期2019-02-07

產品代碼FTM

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2019-02-07 under 510(k) number K182259. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal?

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is a medical device that received FDA 510(k) clearance on 2019-02-07. The listed applicant is Acell, Inc.. The 510(k) number is K182259.

When did Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal receive FDA 510(k) clearance?

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal received FDA 510(k) clearance on 2019-02-07, under 510(k) number K182259.

Who is the listed applicant for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal?

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

What is the FDA product code for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal?

The FDA product code for Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal is FTM.

其他以 Acell, 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。

K241706MicroMatrix® UBM 粒子 K241724Cytal® 瘘傷組織；Cytal® 火傷組織 K230980微矩陣® Flex K191734MatriStem UBM 心包補片 K192725Cytal 瘘傷組織 3 層 K180776Cytal 準創傷微粒

查看所有 11 項裝置 →

相關器械（代碼：FTM）

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。

K262406EluPro 抗生素釋放生物包膜Boston Scientific K250598Endoform 重構模板 - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS（長期可吸收）TELA Bio, Inc.K233991CanGaroo RM 抗菌信封Elutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard 及Supple Peri-GuardSynovis Life Technologies, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。