DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
FDA 510(k) clearance K950956 · decided 1995-06-02
Clearance details
- K-number
- K950956
- Device name
- DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
- Applicant
- Bio-Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-02
- Decision date
- 1995-06-02
- Days to decision
- 92 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Bio-Vascular
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
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
No recalls on record reference this clearance.