Cleared Special

K251567 - NovoSorb BTM (FDA 510(k) Clearance)

K251567 · Polynovo Biomaterials Pty, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
29d
Days
-
Risk

K251567 is an FDA 510(k) clearance for the NovoSorb BTM. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Polynovo Biomaterials Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on June 20, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Polynovo Biomaterials Pty, Ltd. devices

Submission Details

510(k) Number K251567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2025
Decision Date June 20, 2025
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QSZ Absorbable Synthetic Wound Dressing
Device Class -
Definition Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application.

Regulatory Peers - QSZ Absorbable Synthetic Wound Dressing

All 18
Devices cleared under the same product code (QSZ) and FDA review panel - the closest regulatory comparables to K251567.
Redermo Wound Matrix
K260020 · Beijing Kreate Medical Co., Ltd. · Apr 2026
NovoSorb® MTX
K242149 · Polynovo Biomaterials Pty, Ltd. · Mar 2025
SiOxD® Wound Matrix
K241660 · Sioxmed, LLC · Jul 2024
SiOxD Wound Matrix
K232847 · Sioxmed, LLC · Dec 2023
Restrata® MiniMatrix
K223725 · Acera Surgical, Inc. · May 2023
SiOxD Wound Matrix
K222189 · Sioxmed, LLC · Nov 2022