DURA-GUARD - DURAL REPAIR PATCH
FDA 510(k) clearance K982282 · decided 1998-07-30
Clearance details
- K-number
- K982282
- Device name
- DURA-GUARD - DURAL REPAIR PATCH
- Applicant
- Bio-Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-30
- Decision date
- 1998-07-30
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GXQ
- Device class
- 2
- Regulation number
- 882.5910
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Collagen Dura Regeneration Membrane - Repair (K251191) | Collagen Matrix, Inc. | 2025-11-18 |
| Helios Dura Regeneration Matrix (K250420) | Helios Biomedical, Inc. | 2025-05-14 |
| ArtiFascia (K223445) | Nurami Medical , Ltd. | 2023-08-10 |
| SyntheCel Dura Repair (K212943) | Synthes (USA) Products, LLC | 2022-01-28 |
| XenoSure Dura Biologic Patch (K183513) | LeMaitre Vascular, Inc. | 2019-06-13 |
| Cerafix Dura Substitute (K172603) | Acera Surgical, Inc. | 2017-11-27 |
| DuraGen Secure Dural Regeneration Matrix (K163456) | Integra LifeSciences Corporation | 2017-01-06 |
| Durepair Dura Regeneration Matrix (K161370) | Medtronic Neurosurgery | 2016-11-02 |
| Cerafix Dura Substitute (K161278) | Acera Surgical, Inc. | 2016-08-08 |
| Cerafix Dura Substitute (K153613) | Acera Surgical, Inc. | 2016-03-16 |
| Collagen Dural Regeneration Matrix (K150825) | Collagen Matrix, Inc. | 2015-11-20 |
| DURAFORM Dural Graft Implant (K152481) | Codman & Shurtleff, Inc. | 2015-10-30 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the recall (Z-0339-2014) | Synovis Surgical Innovations, Inc. | 2013-11-18 |