Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute
FDA 510(k) K950956 · Bio-Vascular, Inc.
510(k) numberK950956
Submission
- Device name
- Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute
- Applicant
- Bio-Vascular, Inc.
St. Paul, MN, US - Received
- March 2, 1995
- Decision date
- June 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K002233 | Bvi SlingPAJ · Traditional | 10/13/2000SE |
| K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…FTM · Traditional | 02/22/2000SE |
| K983602 | CV Peri-Guard and Vascu-GuardDXZ · Special | 11/12/1998SE |
| K983581 | Ocu-Guard and Ocu-Guard SuppleHQX · Special | 11/06/1998SE |
| K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…FTM · Special | 10/09/1998SE |
| K981624 | Flo-ThruDXC · Traditional | 08/04/1998SE |
| K982282 | Dura-Guard - Dural Repair PatchGXQ · Special | 07/30/1998SE |
| K971726 | CV Peri-Guard - Cardiovascular PatchDXZ · Traditional | 04/10/1998SE |
| K973706 | Dura-Guard-Dural Repair PatchGXQ · Traditional | 12/24/1997SE |
| K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapMTZ · Traditional | 12/16/1997SE |
Questions and answers
When was Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute cleared by the FDA?
Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute (K950956) received a 510(k) decision of Substantially Equivalent on June 2, 1995, 92 days after the submission was received.
What is the product code of K950956?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.