Cleared Special

K241660 - SiOxD® Wound Matrix (FDA 510(k) Clearance)

K241660 · Sioxmed, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
25d
Days
-
Risk

K241660 is an FDA 510(k) clearance for the SiOxD® Wound Matrix. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Sioxmed, LLC (Clemmons, US). The FDA issued a Cleared decision on July 5, 2024 after a review of 25 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 Sioxmed, LLC devices

Submission Details

510(k) Number K241660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2024
Decision Date July 05, 2024
Days to Decision 25 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
89d faster than avg
Panel avg: 114d · This submission: 25d
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 Consultant

Secure BioMed Evaluations
Justin Gracyalny

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K241660.
Redermo Wound Matrix
K260020 · Beijing Kreate Medical Co., Ltd. · Apr 2026
NovoSorb BTM
K251567 · Polynovo Biomaterials Pty, Ltd. · Jun 2025
NovoSorb® MTX
K242149 · Polynovo Biomaterials Pty, Ltd. · Mar 2025
SiOxD Wound Matrix
K232847 · Sioxmed, LLC · Dec 2023
Restrata® MiniMatrix
K223725 · Acera Surgical, Inc. · May 2023
SiOxD Wound Matrix
K222189 · Sioxmed, LLC · Nov 2022