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FDA 510(k)

Fibrillar Collagen Wound Dressing

K-Number: K213341 · 2022-05-31

ApplicantCollagen Matrix, Inc.
Decision Date2022-05-31
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Fibrillar Collagen Wound Dressing is a medical device manufactured by Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2022-05-31 under approval number K213341. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Collagen Matrix, Inc.. The 510(k) number is K213341.

When was Fibrillar Collagen Wound Dressing approved by the FDA?

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

What company makes Fibrillar Collagen Wound Dressing?

Fibrillar Collagen Wound Dressing is manufactured by Collagen Matrix, Inc..

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

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

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Collagen Matrix, Inc.

K152600Collagen Dental Wound Dressings K171008Anorganic Bone Mineral with Collagen in Delivery Applicator K170541Anorganic Bone Mineral in Delivery Applicator K170656Reinforced Flexible Collagen Nerve Cuff K162158Porcine Anorganic Bone Mineral in Delivery Applicator K182074Mineral Collagen Composite Bioactive Moldable

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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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