Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Engineered Tissue Solutions, LLC. It received FDA 510(k) clearance on 2016-09-15 under 510(k) 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. The listed applicant is Engineered Tissue Solutions, LLC. The 510(k) number is K161067.

When did Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” receive FDA 510(k) clearance?

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 510(k) number K161067.

Who is the listed applicant for Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”?

The FDA 510(k) record lists Engineered Tissue Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07647705Borate-based Bioactive Glass Fiber Matrix (BBGFM) in the Treatment of Venus Leg Ulcers (VLU)NOT_YET_RECRUITINGNCT06598241Mirragen Diabetic Foot Ulcer StudyRECRUITING

Related Devices (Code: QSZ)

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.

K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.K242149NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.K241660SiOxD® Wound MatrixSioxmed, LLCK232847SiOxD Wound MatrixSioxmed, LLCK223725Restrata® MiniMatrixAcera Surgical, Inc.

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.

↑