Helios Dura Regeneration Matrix
FDA 510(k) K250420 · Helios Biomedical, Inc.
510(k) numberK250420
Submission
- Device name
- Helios Dura Regeneration Matrix
- Applicant
- Helios Biomedical, Inc.
Weston, MA, US - Received
- February 13, 2025
- Decision date
- May 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - RepairGXQ · Traditional | Collagen Matrix, Inc. | 11/18/2025SE |
| K223445 | ArtiFasciaGXQ · Traditional | Nurami Medical , Ltd. | 08/10/2023SE |
| K212943 | SyntheCel Dura RepairGXQ · Traditional | Synthes (USA) Products, LLC | 01/28/2022SE |
| K183513 | XenoSure Dura Biologic PatchGXQ · Traditional | LeMaitre Vascular, Inc. | 06/13/2019SE |
| K172603 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 11/27/2017SE |
| K163456 | DuraGen Secure Dural Regeneration MatrixGXQ · Special | Integra LifeSciences Corporation | 01/06/2017SE |
| K161370 | Durepair Dura Regeneration MatrixGXQ · Traditional | Medtronic Neurosurgery | 11/02/2016SE |
| K161278 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 08/08/2016SE |
| K153613 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 03/16/2016SE |
| K150825 | Collagen Dural Regeneration MatrixGXQ · Traditional | Collagen Matrix, Inc. | 11/20/2015SE |
More from Collagen Matrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250397 | Helios Dermal ScaffoldKGN · Traditional | 08/15/2025SE |
Questions and answers
When was Helios Dura Regeneration Matrix cleared by the FDA?
Helios Dura Regeneration Matrix (K250420) received a 510(k) decision of Substantially Equivalent on May 14, 2025, 90 days after the submission was received.
What is the product code of K250420?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.