HYALOMATRIX— 510(k) K261311
Substantially EquivalentAnika Therapeutics, Inc.
FDA 510(k) clearance K261311 for HYALOMATRIX, Substantially Equivalent on 2026-09-02. Applicant: Anika Therapeutics, Inc.. Device class: Unclassified.
Summary
HYALOMATRIX is from Anika Therapeutics, Inc., filed under product code QSZ (Absorbable Synthetic Wound Dressing). The record doesn't describe the dressing beyond its name and code.
Class U, with no regulation number. The classification panel is listed as Unknown, and the General, Plastic Surgery review panel handled it as a Traditional 510(k). The decision was Substantially Equivalent.
The record lists Anika's location as Beford, Massachusetts. The decision came 134 calendar days after receipt (April 21 to September 2, 2026).
Clearance details
- Applicant
- Anika Therapeutics, Inc.
- Product code
- Product code QSZ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beford, MA, US
Recent devices under product code QSZ
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