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FDA 510(k)

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”

K-Number: K161067 · 2016-09-15

ApplicantEngineered Tissue Solutions, LLC
Decision Date2016-09-15
Product CodeQSZ
DecisionSubstantially Equivalent

Device Summary

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” is a medical device manufactured by Engineered Tissue Solutions, LLC. It received FDA 510(k) clearance on 2016-09-15 under approval number K161067. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”?

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” is a medical device that received FDA 510(k) clearance on 2016-09-15. It is manufactured by Engineered Tissue Solutions, LLC. The 510(k) number is K161067.

When was Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” approved by the FDA?

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” received FDA 510(k) clearance on 2016-09-15, under approval number K161067.

What company makes Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”?

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” is manufactured by Engineered Tissue Solutions, LLC.

What is the FDA product code for Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”?

The FDA product code for Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” is QSZ.

Related Clinical Trials

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Related Devices (Code: QSZ)

K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)Polynovo Biomaterials Pty, Ltd. K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH K170300Restrata Wound MatrixAcera Surgical, Inc. K173544Phoenix Wound MatrixNanofiber Solutions, Inc. K193583Restrata®Acera Surgical, Inc. K222189SiOxD Wound MatrixSioxmed, LLC

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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