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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 the device name listed in this FDA 510(k) record. The listed applicant is Reprise Biomedical, Inc.. It received FDA 510(k) clearance on 2023-12-13 under 510(k) 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. The listed applicant is Reprise Biomedical, Inc.. The 510(k) number is K231614.

When did MiroTract Wound Matrix receive FDA 510(k) clearance?

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

Who is the listed applicant for MiroTract Wound Matrix?

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

What is the FDA product code for MiroTract Wound Matrix?

The FDA product code for MiroTract Wound Matrix 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.

NCT07632001Miro3D Wound Matrix for Treatment of Diabetic Foot UlcersRECRUITING

Other records listing Reprise Biomedical, 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.

K240753Miro3D Fibers Wound MatrixK240277MiroDry Wound MatrixK223257Miro3D Wound MatrixK221520Miro3D Wound Matrix

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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