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FDA 510(k)

ABCcolla Collagen Matrix

K-Number: K162348 · 2017-05-10

ApplicantAcro Biomedical Co., Ltd.
Decision Date2017-05-10
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

ABCcolla Collagen Matrix is a medical device manufactured by Acro Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-10 under approval 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. It is manufactured by Acro Biomedical Co., Ltd.. The 510(k) number is K162348.

When was ABCcolla Collagen Matrix approved by the FDA?

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

What company makes ABCcolla Collagen Matrix?

ABCcolla Collagen Matrix is manufactured by Acro Biomedical Co., Ltd..

What is the FDA product code for ABCcolla Collagen Matrix?

The FDA product code for ABCcolla Collagen Matrix is KGN.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT05081284 Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix ACTIVE_NOT_RECRUITING NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT07219316 Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision COMPLETED

Other Devices by Acro Biomedical Co., Ltd.

K171629ABCcolla Bone Graft K212156ABCcolla Bone Matrix K233378ABCcolla® Collagen ADM Scaffold

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

View on FDA Database →

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

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