Preclude MVP Dura Substitute
FDA 510(k) K021477 · W. L. Gore & Associates, Inc.
510(k) numberK021477
Submission
- Device name
- Preclude MVP Dura Substitute
- Applicant
- W. L. Gore & Associates, Inc.
Flagstaff, AZ, US - Received
- May 8, 2002
- Decision date
- November 8, 2002
- 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 |
|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon CatheterDQY · Traditional | 06/02/2025SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 03/01/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | 06/23/2023SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | 07/31/2019SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | 08/17/2018SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | 04/05/2018SE |
| K163576 | GORE SYNECOR Preperitoneal BiomaterialFTL · Traditional | 05/11/2017SE |
| K170740 | GORE VIABIL Short Wire Biliary EndoprosthesisFGE · Traditional | 05/08/2017SESU |
Questions and answers
When was Preclude MVP Dura Substitute cleared by the FDA?
Preclude MVP Dura Substitute (K021477) received a 510(k) decision of Substantially Equivalent on November 8, 2002, 184 days after the submission was received.
What is the product code of K021477?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.