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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 the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) 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. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K213341.

When did Fibrillar Collagen Wound Dressing receive FDA 510(k) clearance?

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

Who is the listed applicant for Fibrillar Collagen Wound Dressing?

The FDA 510(k) record lists Collagen Matrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07546279The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.RECRUITINGNCT07613775Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival RecessionsNOT_YET_RECRUITINGNCT07782125Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue DefectsRECRUITINGNCT07409571Palatal Wound Healing After Free Gingival Graft SurgeryRECRUITINGNCT07788846Collagen, Bone Wax or Compression for Cancellous Bone Bleeding After Single-Ray AmputationNOT_YET_RECRUITING

Other records listing Collagen Matrix, Inc. 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.

K251191Collagen Dura Regeneration Membrane - RepairK243071Bovine Dermis Collagen Dermal MatrixK242302RejuvaKnee™ Collagen Meniscus ImplantK233203Soft Tissue Augmentation Resorbable MatrixK240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixK231942Mineral Collagen Composite Bioactive Extra Moldable

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Related Devices (Code: KGN)

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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform 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

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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