FDA 510(k)

纖維膠原蛋白傷口敷料

K 號：K213341 · 2022-05-31

決定日期2022-05-31

產品代碼KGN

決定相當於

器材摘要

Fibrillar Collagen Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K213341. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Fibrillar Collagen Wound Dressing?

Fibrillar Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K213341.

When did Fibrillar Collagen Wound Dressing receive FDA 510(k) clearance?

Fibrillar Collagen Wound Dressing received FDA 510(k) clearance on 2022-05-31, under 510(k) number K213341.

Who is the listed applicant for Fibrillar Collagen Wound Dressing?

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

What is the FDA product code for Fibrillar Collagen Wound Dressing?

The FDA product code for Fibrillar Collagen Wound Dressing is KGN.

其他以 Collagen Matrix, 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。

K251191膠原蛋白杜拉再生薄膜 - 修復 K243071牛真皮膠原膚質基質 K242302RejuvaKnee™ 膝蓋軟骨植入體 K233203軟組織增強可吸收網格 K240424礦物膠原蛋白複合生物活性可塑骨移植基质 K231942礦物膠原蛋白複合生物活性超可塑材

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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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