FDA 510(k)

SiOxD® 瘘管組織

K 號：K241660 · 2024-07-05

決定日期2024-07-05

產品代碼QSZ

決定相當於

器材摘要

SiOxD® Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Sioxmed, LLC. It received FDA 510(k) clearance on 2024-07-05 under 510(k) number K241660. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

常見問題

What is the SiOxD® Wound Matrix?

SiOxD® Wound Matrix is a medical device that received FDA 510(k) clearance on 2024-07-05. The listed applicant is Sioxmed, LLC. The 510(k) number is K241660.

When did SiOxD® Wound Matrix receive FDA 510(k) clearance?

SiOxD® Wound Matrix received FDA 510(k) clearance on 2024-07-05, under 510(k) number K241660.

Who is the listed applicant for SiOxD® Wound Matrix?

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

What is the FDA product code for SiOxD® Wound Matrix?

The FDA product code for SiOxD® Wound Matrix is QSZ.

其他以 Sioxmed, LLC 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。

K250890SBC1 製劑 K242406SiOxC膚膏 K232847SiOxD 瘘傷組織 K222189SiOxD 瘘傷組織

相關器械（代碼：QSZ）

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。

K261311HYALOMATRIXAnika Therapeutics, Inc.K254256LOUFUCON® 黃金創傷組織Huizhou Foryou Medical Devices Co., Ltd.K260020Redermo 瘘傷組織Beijing Kreate Medical Co., Ltd.K251567新索爾BTMPolynovo Biomaterials Pty, Ltd.K242149NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.K232847SiOxD 瘘傷組織Sioxmed, LLC

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。