Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft
FDA 510(k) K131015 · Cook Biotech, Inc.
510(k) numberK131015
Submission
- Device name
- Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft
- Applicant
- Cook Biotech, Inc.
West Lafayette, IN, US - Received
- April 11, 2013
- Decision date
- October 8, 2013
- 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 |
| 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 |
More from Acera Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…KHJ · Traditional | 05/24/2024SE |
| K201000 | Biodesign Staple Line ReinforcementFTM · Traditional | 07/13/2020SE |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…OXN · Traditional | 12/27/2019SE |
| K171817 | Biodesign Diaphragmatic Hernia GraftFTM · Traditional | 03/13/2018SE |
| K162934 | Biodesign Parastomal Hernia Repair GraftFTM · Traditional | 07/10/2017SE |
| K170016 | Biodesign Fistula PlugFTM · Traditional | 06/21/2017SE |
| K170945 | Biodesign Staple Line ReinforcementOXE · Special | 04/28/2017SE |
| K161762 | DynaMatrix/Dynamatrix PlusNPL · Special | 01/13/2017SE |
| K162741 | AxoGuard Nerve ConnectorJXI · Special | 10/31/2016SE |
| K160136 | Flowable Wound MatrixKGN · Traditional | 09/28/2016SE |
Questions and answers
When was Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft cleared by the FDA?
Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft (K131015) received a 510(k) decision of Substantially Equivalent on October 8, 2013, 180 days after the submission was received.
What is the product code of K131015?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.