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., Sioxmed, LLC and Acera Surgical, Inc..

19
Total
19
Cleared
141d
Avg days
2003
Since
Declining activity - 3 submissions in the last 2 years vs 5 in the prior period
Review times improving: avg 118d recently vs 145d historically

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

19 devices
1–19 of 19
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 May 07, 2014
GORE BIO-A WOUND MATRIX
K132397
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 279d

About Product Code QSZ - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code QSZ since 2003, with 19 receiving FDA clearance (average review time: 141 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.

FDA 510(k) Review Time - QSZ Product Code

Recent submissions under QSZ have taken an average of 118 days to reach a decision - down from 145 days historically, suggesting improved FDA processing for this classification.

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