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FDA 510(k)

Miro3D Wound Matrix

K-Number: K221520 · 2022-08-18

ApplicantReprise Biomedical, Inc.
Decision Date2022-08-18
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Miro3D Wound Matrix is a medical device manufactured by Reprise Biomedical, Inc.. It received FDA 510(k) clearance on 2022-08-18 under approval number K221520. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miro3D Wound Matrix?

Miro3D Wound Matrix is a medical device that received FDA 510(k) clearance on 2022-08-18. It is manufactured by Reprise Biomedical, Inc.. The 510(k) number is K221520.

When was Miro3D Wound Matrix approved by the FDA?

Miro3D Wound Matrix received FDA 510(k) clearance on 2022-08-18, under approval number K221520.

What company makes Miro3D Wound Matrix?

Miro3D Wound Matrix is manufactured by Reprise Biomedical, Inc..

What is the FDA product code for Miro3D Wound Matrix?

The FDA product code for Miro3D Wound Matrix is KGN.

Related Clinical Trials

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Other Devices by Reprise Biomedical, Inc.

K231614MiroTract 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.

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