FDA 510(k)

ABCcolla® Collagen ADM Scaffold

K-Number: K233378 · 2024-10-18

Decision Date2024-10-18

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

ABCcolla® Collagen ADM Scaffold is a medical device manufactured by Acro Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2024-10-18 under approval number K233378. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Acro Biomedical Co., Ltd.. The 510(k) number is K233378.

When was ABCcolla® Collagen ADM Scaffold approved by the FDA?

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

What company makes ABCcolla® Collagen ADM Scaffold?

ABCcolla® Collagen ADM Scaffold is manufactured by Acro Biomedical Co., Ltd..

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

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

Related Clinical Trials

NCT07219316 Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision COMPLETED

Other Devices by Acro Biomedical Co., Ltd.

K162348ABCcolla Collagen Matrix K171629ABCcolla Bone Graft K212156ABCcolla Bone Matrix

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.