FDA 510(k)

Cytal® 瘘傷組織；Cytal® 火傷組織

K 號：K241724 · 2024-07-11

決定日期2024-07-11

產品代碼KGN

決定相當於

器材摘要

Cytal® Wound Matrix; Cytal® Burn Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2024-07-11 under 510(k) number K241724. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Cytal® Wound Matrix; Cytal® Burn Matrix?

Cytal® Wound Matrix; Cytal® Burn Matrix is a medical device that received FDA 510(k) clearance on 2024-07-11. The listed applicant is Acell, Inc.. The 510(k) number is K241724.

When did Cytal® Wound Matrix; Cytal® Burn Matrix receive FDA 510(k) clearance?

Cytal® Wound Matrix; Cytal® Burn Matrix received FDA 510(k) clearance on 2024-07-11, under 510(k) number K241724.

Who is the listed applicant for Cytal® Wound Matrix; Cytal® Burn Matrix?

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 Cytal® Wound Matrix; Cytal® Burn Matrix?

The FDA product code for Cytal® Wound Matrix; Cytal® Burn Matrix is KGN.

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 K230980微矩陣® Flex K191734MatriStem UBM 心包補片 K192725Cytal 瘘傷組織 3 層 K182259Gentrix外科馬特拉克斯，Gentrix外科馬特拉克斯高位 K180776Cytal 準創傷微粒

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相關器械（代碼：KGN）

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。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 外科維網，1cc（CG-01AP）；Accelagen Plus 外科維網，3cc（CG-03AP）；Accelagen Plus 外科維網，5cc（CG-05AP）；Accelagen Plus 外科條，125x25x2mm（CG-125X25AP）；Accelagen Plus 外科條，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596膠原蛋白傷口粉末Ventris Medical K260669Endoform皮膚模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMD 医療設備規範文本翻譯： ECMT-100 WMD 医療設備規範文本Ecm Therapeutics, Inc.K253204催化BioTissue Holdings, Inc.

官方來源

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