Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MiroTract Wound Matrix

K-Number: K231614 · 2023-12-13

ApplicantReprise Biomedical, Inc.
Decision Date2023-12-13
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MiroTract Wound Matrix is a medical device manufactured by Reprise Biomedical, Inc.. It received FDA 510(k) clearance on 2023-12-13 under approval number K231614. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiroTract Wound Matrix?

MiroTract Wound Matrix is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Reprise Biomedical, Inc.. The 510(k) number is K231614.

When was MiroTract Wound Matrix approved by the FDA?

MiroTract Wound Matrix received FDA 510(k) clearance on 2023-12-13, under approval number K231614.

What company makes MiroTract Wound Matrix?

MiroTract Wound Matrix is manufactured by Reprise Biomedical, Inc..

What is the FDA product code for MiroTract Wound Matrix?

The FDA product code for MiroTract Wound Matrix is KGN.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT06073808 The Role of Amnion Membrane Allografts in Nipple Preservation NOT_YET_RECRUITING NCT06919809 Effectiveness and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix for Wound Healing After MOHS Surgery COMPLETED NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT06857708 The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix® RECRUITING

Other Devices by Reprise Biomedical, Inc.

K221520Miro3D Wound Matrix K240753Miro3D Fibers Wound Matrix K240277MiroDry Wound 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

View on FDA Database →

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

↑