Cleared Traditional

K261311 - HYALOMATRIX

K261311 · Anika Therapeutics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
134d
Days
-
Risk

K261311 is an FDA 510(k) clearance for the HYALOMATRIX. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Anika Therapeutics, Inc. (Beford, US). The FDA issued a Cleared decision on September 2, 2026 after a review of 134 days - within the typical 510(k) review window.

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 Anika Therapeutics, Inc. devices

FDA 510(k) Submission Details - K261311

510(k) Number K261311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2026
Decision Date September 02, 2026
Days to Decision 134 days
Submission Type Traditional
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
19d slower than avg
Panel avg: 115d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

QSZ Device Classification - Class 0,

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

Anika Therapeutics Srl
Monica Fabris

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 19
Devices cleared under the same product code (QSZ) and FDA review panel - the closest regulatory comparables to K261311.
LUOFUCON® Wound Matrix
K254256 · Huizhou Foryou Medical Devices Co., Ltd. · Aug 2026
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