FDA 510(k)

ABCcolla® 胶原 ADM 架架

K号: K233378 · 2024-10-18

决定日期2024-10-18

产品代码KGN

决定实质等同

器械摘要

ABCcolla® Collagen ADM Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Acro Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K233378. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the ABCcolla® Collagen ADM Scaffold?

ABCcolla® Collagen ADM Scaffold is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Acro Biomedical Co., Ltd.. The 510(k) number is K233378.

When did ABCcolla® Collagen ADM Scaffold receive FDA 510(k) clearance?

ABCcolla® Collagen ADM Scaffold received FDA 510(k) clearance on 2024-10-18, under 510(k) number K233378.

Who is the listed applicant for ABCcolla® Collagen ADM Scaffold?

The FDA 510(k) record lists Acro Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABCcolla® Collagen ADM Scaffold?

The FDA product code for ABCcolla® Collagen ADM Scaffold is KGN.

列明Acro Biomedical Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K212156ABCcolla 骨基质 K171629ABCcolla 骨移植材料 K162348ABCcolla 胶原基质

相关器械（代码：KGN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 手术基质，1cc（CG-01AP）；Accelagen Plus 手术基质，3cc（CG-03AP）；Accelagen Plus 手术基质，5cc（CG-05AP）；Accelagen Plus 手术条带，125x25x2mm（CG-125X25AP）；Accelagen Plus 手术条带，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596胶原蛋白伤口粉Ventris Medical K260669Endoform 皮肤模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

官方来源

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