XenoSure Dura Biologic Patch
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183513 FDA 510(k)
- FDA Product Code
- GXQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5910 FDA 510(k)
- Regulation Number
- 882.5910 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The XenoSure Dura Biologic Patch is a Dura Substitute (per FDA nomenclature), a biologic material derived from bovine pericardium designed to repair and close defects in the dura mater during neurosurgical procedures. It provides structural reinforcement to support tissue integration and wound healing in cranial surgeries.
This patch is supplied sterile and intended for single-use in neurosurgical settings. It is classified as a Class II medical device under FDA regulations (21 CFR 882.5910) and has received FDA 510K clearance and MDD compliance. Available in various sizes, it is intended for direct application to dura mater defects, requiring no additional preparation beyond sterile handling as per surgical protocols.
Frequently asked questions
What types of neurosurgical procedures is the XenoSure Dura Biologic Patch designed to support?
The XenoSure Dura Biologic Patch is specifically designed to repair and close defects in the dura mater during neurosurgical procedures, such as cranial surgeries. It provides structural reinforcement to support tissue integration and wound healing where dura mater is damaged or missing.
Is the XenoSure Dura Biologic Patch reusable, or is it intended for single-use only?
The XenoSure Dura Biologic Patch is explicitly supplied sterile and intended for single-use in neurosurgical settings. This ensures patient safety and maintains sterility throughout the procedure, as reuse is not recommended.
What sizes are available for the XenoSure Dura Biologic Patch, and how are they selected?
The XenoSure Dura Biologic Patch is available in multiple sizes to accommodate various dura mater defect sizes. The exact dimensions are not specified in the data, but the product is designed for direct application to defects, so selection should be based on preoperative measurements or intraoperative assessment to ensure proper coverage.
How should the XenoSure Dura Biologic Patch be stored before use, and what are the key handling instructions?
While specific storage conditions (e.g., temperature, humidity) are not detailed, the patch is supplied sterile and requires sterile handling per surgical protocols. It should be stored in its original packaging until use, protected from contamination, and prepared in a sterile field prior to application to the dura mater.
What regulatory pathway was followed for FDA clearance of the XenoSure Dura Biologic Patch, and what does this mean for clinicians?
The XenoSure Dura Biologic Patch received FDA 510(k) clearance through a Traditional review pathway, determined to be *substantially equivalent* to a legally marketed predicate device. This means it has undergone rigorous evaluation by the FDA’s Neurology (NE) Advisory Committee to ensure safety and effectiveness as a dura substitute, providing confidence in its clinical use for neurosurgical applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: XenoSure® Biologic Patch - LeMaitre, XenoSure® Biologic Patch - LeMaitre, June 13, 2019 LeMaitre Vascular Inc. Xiang Zhang Vice President of ..., PDF XenoSure® Biologic Patch - lemaitre.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K183513 | Class II | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (2)
- FDA 510(k) K183513 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026