Collagen Dura Regeneration Membrane - Repair
FDA 510(k) K251191 · Collagen Matrix, Inc.
510(k) numberK251191
Submission
- Device name
- Collagen Dura Regeneration Membrane - Repair
- Applicant
- Collagen Matrix, Inc.
Oakland, NJ, US - Received
- April 17, 2025
- Decision date
- November 18, 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 |
|---|---|---|---|
| K250420 | Helios Dura Regeneration MatrixGXQ · Traditional | Helios Biomedical, Inc. | 05/14/2025SE |
| 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 |
|---|---|---|
| K243071 | Bovine Dermis Collagen Dermal MatrixKGN · Traditional | 12/19/2024SE |
| K242302 | RejuvaKnee Collagen Meniscus ImplantOLC · Traditional | 10/02/2024SE |
| K233203 | Soft Tissue Augmentation Resorbable MatrixNPL · Traditional | 05/01/2024SE |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixMQV · Traditional | 03/12/2024SE |
| K231942 | Mineral Collagen Composite Bioactive Extra MoldableMQV · Special | 08/02/2023SE |
| K221735 | Mineral Collagen Composite Bioactive MoldableMQV · Traditional | 12/20/2022SE |
| K213341 | Fibrillar Collagen Wound DressingKGN · Traditional | 05/31/2022SE |
| K202183 | Porcine Mineral Collagen CompositeNPM · Traditional | 04/02/2021SE |
| K201859 | Porcine Mineral Collagen Composite MoldableNPM · Traditional | 09/11/2020SE |
| K182074 | Mineral Collagen Composite Bioactive MoldableMQV · Traditional | 03/21/2019SE |
Questions and answers
When was Collagen Dura Regeneration Membrane - Repair cleared by the FDA?
Collagen Dura Regeneration Membrane - Repair (K251191) received a 510(k) decision of Substantially Equivalent on November 18, 2025, 215 days after the submission was received.
What is the product code of K251191?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.