510(k) K261311
K261311 is an FDA 510(k) premarket notification submitted by Anika Therapeutics, Inc. for the device "HYALOMATRIX". The FDA issued a decision of Substantially Equivalent on September 2, 2026. The device falls under product code QSZ (Absorbable Synthetic Wound Dressing), a Class U device. Anika Therapeutics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2026
- Date Received
- April 21, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Synthetic Wound Dressing
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.