FDA 510(k)

ABCcolla Collagen Matrix

K-Number: K162348 · 2017-05-10

Decision Date2017-05-10

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

ABCcolla Collagen Matrix 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 2017-05-10 under 510(k) number K162348. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABCcolla Collagen Matrix?

ABCcolla Collagen Matrix is a medical device that received FDA 510(k) clearance on 2017-05-10. The listed applicant is Acro Biomedical Co., Ltd.. The 510(k) number is K162348.

When did ABCcolla Collagen Matrix receive FDA 510(k) clearance?

ABCcolla Collagen Matrix received FDA 510(k) clearance on 2017-05-10, under 510(k) number K162348.

Who is the listed applicant for ABCcolla Collagen Matrix?

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 Matrix?

The FDA product code for ABCcolla Collagen Matrix is KGN.

Other records listing Acro Biomedical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233378ABCcolla® Collagen ADM Scaffold K212156ABCcolla Bone Matrix K171629ABCcolla Bone Graft

Related Devices (Code: KGN)

K260596Collagen Wound PowderVentris Medical K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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.