FDA 510(k)

SiOxD 瘘傷組織

K 號：K232847 · 2023-12-18

決定日期2023-12-18

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 2023-12-18 under 510(k) number K232847. 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 2023-12-18. The listed applicant is Sioxmed, LLC. The 510(k) number is K232847.

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

SiOxD Wound Matrix received FDA 510(k) clearance on 2023-12-18, under 510(k) number K232847.

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 K241660SiOxD® 瘘管組織 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.K241660SiOxD® 瘘管組織Sioxmed, LLC

官方來源

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