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FDA 510(k)

MicroMatrix® Flex

K-Number: K230980 · 2023-09-22

ApplicantAcell, Inc.
Decision Date2023-09-22
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MicroMatrix® Flex is a medical device manufactured by Acell, Inc.. It received FDA 510(k) clearance on 2023-09-22 under approval number K230980. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicroMatrix® Flex?

MicroMatrix® Flex is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by Acell, Inc.. The 510(k) number is K230980.

When was MicroMatrix® Flex approved by the FDA?

MicroMatrix® Flex received FDA 510(k) clearance on 2023-09-22, under approval number K230980.

What company makes MicroMatrix® Flex?

MicroMatrix® Flex is manufactured by Acell, Inc..

What is the FDA product code for MicroMatrix® Flex?

The FDA product code for MicroMatrix® Flex is KGN.

Other Devices by Acell, Inc.

K162554Gentrix Surgical Matrix K153754MicroMatrix K172399MicroMatrix K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend K180776Cytal Wound Particulate K191734MatriStem UBM Pericardial Patch

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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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