Cleared Traditional

K223725 - Restrata® MiniMatrix (FDA 510(k) Clearance)

K223725 · Acera Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
156d
Days
-
Risk

K223725 is an FDA 510(k) clearance for the Restrata® MiniMatrix. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Acera Surgical, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 18, 2023 after a review of 156 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Acera Surgical, Inc. devices

Submission Details

510(k) Number K223725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2022
Decision Date May 18, 2023
Days to Decision 156 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 114d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

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 K223725.
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
K241660 · Sioxmed, LLC · Jul 2024
SiOxD Wound Matrix
K232847 · Sioxmed, LLC · Dec 2023
SiOxD Wound Matrix
K222189 · Sioxmed, LLC · Nov 2022