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..
FDA 510(k) Cleared Absorbable Synthetic Wound Dressing Devices (Product Code QSZ)
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 remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
Recent submissions under QSZ have taken an average of 95 days to reach a decision - down from 153 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 →