Cleared Traditional

K170300 - Restrata Wound Matrix (FDA 510(k) Clearance)

K170300 · Acera Surgical, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2017
Decision
85d
Days
-
Risk

K170300 is an FDA 510(k) clearance for the Restrata Wound Matrix. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Acera Surgical, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 26, 2017 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acera Surgical, Inc. devices

Submission Details

510(k) Number K170300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2017
Decision Date April 26, 2017
Days to Decision 85 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
29d faster than avg
Panel avg: 114d · This submission: 85d
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 K170300.
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
Restrata® MiniMatrix
K223725 · Acera Surgical, Inc. · May 2023