Hyalomatrix
FDA 510(k) K261311 · Anika Therapeutics, Inc.
510(k) numberK261311
Submission
- Device name
- Hyalomatrix
- Applicant
- Anika Therapeutics, Inc.
Beford, MA, US - Received
- April 21, 2026
- Decision date
- September 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QSZ – Absorbable Synthetic Wound Dressing
- Device class
- Unclassified
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Other 510(k)s with product code QSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254256 | LUOFUCON® Wound MatrixQSZ · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 08/18/2026SE |
| K260020 | Redermo Wound MatrixQSZ · Traditional | Beijing Kreate Medical Co., Ltd. | 04/16/2026SE |
| K251567 | NovoSorb BTMQSZ · Special | Polynovo Biomaterials Pty, Ltd. | 06/20/2025SE |
| K242149 | NovoSorb® MTXQSZ · Traditional | Polynovo Biomaterials Pty, Ltd. | 03/05/2025SE |
| K241660 | SiOxD® Wound MatrixQSZ · Special | Sioxmed, LLC | 07/05/2024SE |
| K232847 | SiOxD Wound MatrixQSZ · Traditional | Sioxmed, LLC | 12/18/2023SE |
| K223725 | Restrata® MiniMatrixQSZ · Traditional | Acera Surgical, Inc. | 05/18/2023SE |
| K222189 | SiOxD Wound MatrixQSZ · Traditional | Sioxmed, LLC | 11/18/2022SE |
| K221686 | NovoSorb MatrixQSZ · Special | Polynovo Biomaterials Pty, Ltd. | 09/15/2022SE |
| K193583 | Restrata®QSZ · Special | Acera Surgical, Inc. | 09/25/2020SE |
More from Acera Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250997 | Integrity ImplantOWX · Traditional | 06/17/2025SE |
| K231968 | Tactoset® Injectable Bone SubstituteMQV · Traditional | 12/20/2023SE |
| K223538 | Integrity ImplantOWX · Traditional | 08/17/2023SE |
| K223860 | Integrity Bone Staple Fixation SystemMBI · Traditional | 05/22/2023SE |
| K222487 | Anika Tissue Tack Fixation SystemGDW · Traditional | 05/08/2023SE |
| K223915 | TactosetMQV · Traditional | 03/29/2023SE |
| K212083 | Tactoset Injectable Bone SubstituteMQV · Traditional | 08/31/2021SE |
| K190956 | SCS 17-01MQV · Traditional | 01/30/2020SE |
| K173008 | SCS 17-01MQV · Traditional | 12/26/2017SE |
Questions and answers
When was Hyalomatrix cleared by the FDA?
Hyalomatrix (K261311) received a 510(k) decision of Substantially Equivalent on September 2, 2026, 134 days after the submission was received.
What is the product code of K261311?
The FDA product code is QSZ – Absorbable Synthetic Wound Dressing, a Unclassified device.