QSZ

FDA Product Code QSZ: Absorbable Synthetic Wound Dressing

Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application.

Leading manufacturers include Polynovo Biomaterials Pty, Ltd., Acera Surgical, Inc. and Sioxmed, LLC.

20
Total
20
Cleared
145d
Avg days
2003
Since
Stable submission activity - 4 submissions in the last 2 years
Consistent review times: 147d avg (recent)

FDA 510(k) Cleared Absorbable Synthetic Wound Dressing Devices (Product Code QSZ)

20 devices
1–20 of 20
Cleared Aug 18, 2026
LUOFUCON® Wound Matrix
K254256
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 232d
Cleared Apr 16, 2026
Redermo Wound Matrix
K260020
Beijing Kreate Medical Co., Ltd.
General & Plastic Surgery · 101d
Cleared Jun 20, 2025
NovoSorb BTM
K251567
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 29d
Cleared Mar 05, 2025
NovoSorb® MTX
K242149
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 225d
Cleared Jul 05, 2024
SiOxD® Wound Matrix
K241660
Sioxmed, LLC
General & Plastic Surgery · 25d
Cleared Dec 18, 2023
SiOxD Wound Matrix
K232847
Sioxmed, LLC
General & Plastic Surgery · 95d
Cleared May 18, 2023
Restrata® MiniMatrix
K223725
Acera Surgical, Inc.
General & Plastic Surgery · 156d
Cleared Nov 18, 2022
SiOxD Wound Matrix
K222189
Sioxmed, LLC
General & Plastic Surgery · 119d
Cleared Sep 15, 2022
NovoSorb Matrix
K221686
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 97d
Cleared Sep 25, 2020
Restrata®
K193583
Acera Surgical, Inc.
General & Plastic Surgery · 277d
Cleared Mar 02, 2018
Phoenix Wound Matrix
K173544
Nanofiber Solutions, Inc.
General & Plastic Surgery · 106d
Cleared Aug 11, 2017
NovoSorb 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)
K172140
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 25d
Cleared Jun 28, 2017
SupraSDRM Biodegradable Matrix Wound Dressing
K170213
Polymedics Innovations, GmbH
General & Plastic Surgery · 155d
Cleared Apr 26, 2017
Restrata Wound Matrix
K170300
Acera Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Sep 15, 2016
Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
K161067
Engineered Tissue Solutions, LLC
General & Plastic Surgery · 153d
Cleared Dec 23, 2015
BTM Wound Dressing
K142879
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 447d
Cleared May 07, 2014
GORE BIO-A WOUND MATRIX
K132397
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 279d
Cleared Dec 14, 2007
HYALOMATRIX PA
K073251
Fidia Advanced Biopolymers Srl
General & Plastic Surgery · 25d

About Product Code QSZ - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code QSZ since 2003, with 20 receiving FDA clearance (average review time: 145 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - QSZ Product Code

FDA review times for QSZ submissions have been consistent, averaging 147 days recently vs 145 days historically.

QSZ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →