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

FDA 510(k) K161067 · Engineered Tissue Solutions, LLC

Substantially Equivalent

510(k) numberK161067

Submission

Device name
Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
Applicant
Engineered Tissue Solutions, LLC
Rolla, MO, US
Received
April 15, 2016
Decision date
September 15, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QSZ – Absorbable Synthetic Wound Dressing
Device class
Unclassified

Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.

Other 510(k)s with product code QSZ

510(k)DeviceApplicantDecision
K261311HyalomatrixQSZ · Traditional Anika Therapeutics, Inc.09/02/2026SE
K254256LUOFUCON® Wound MatrixQSZ · Traditional Huizhou Foryou Medical Devices Co., Ltd.08/18/2026SE
K260020Redermo Wound MatrixQSZ · Traditional Beijing Kreate Medical Co., Ltd.04/16/2026SE
K251567NovoSorb BTMQSZ · Special Polynovo Biomaterials Pty, Ltd.06/20/2025SE
K242149NovoSorb® MTXQSZ · Traditional Polynovo Biomaterials Pty, Ltd.03/05/2025SE
K241660SiOxD® Wound MatrixQSZ · Special Sioxmed, LLC07/05/2024SE
K232847SiOxD Wound MatrixQSZ · Traditional Sioxmed, LLC12/18/2023SE
K223725Restrata® MiniMatrixQSZ · Traditional Acera Surgical, Inc.05/18/2023SE
K222189SiOxD Wound MatrixQSZ · Traditional Sioxmed, LLC11/18/2022SE
K221686NovoSorb MatrixQSZ · Special Polynovo Biomaterials Pty, Ltd.09/15/2022SE

Questions and answers

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

Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (K161067) received a 510(k) decision of Substantially Equivalent on September 15, 2016, 153 days after the submission was received.

What is the product code of K161067?

The FDA product code is QSZ – Absorbable Synthetic Wound Dressing, a Unclassified device.