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FDA 510(k)

MiroDry Wound Matrix

K-Number: K240277 · 2024-03-01

ApplicantReprise Biomedical, Inc.
Decision Date2024-03-01
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MiroDry Wound Matrix is a medical device manufactured by Reprise Biomedical, Inc.. It received FDA 510(k) clearance on 2024-03-01 under approval number K240277. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiroDry Wound Matrix?

MiroDry Wound Matrix is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Reprise Biomedical, Inc.. The 510(k) number is K240277.

When was MiroDry Wound Matrix approved by the FDA?

MiroDry Wound Matrix received FDA 510(k) clearance on 2024-03-01, under approval number K240277.

What company makes MiroDry Wound Matrix?

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

What is the FDA product code for MiroDry Wound Matrix?

The FDA product code for MiroDry Wound Matrix is KGN.

Related Clinical Trials

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Other Devices by Reprise Biomedical, Inc.

K221520Miro3D Wound Matrix K231614MiroTract Wound Matrix K240753Miro3D Fibers 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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