GORE BIO-A WOUND MATRIX
FDA 510(k) clearance K132397 · decided 2014-05-07
Clearance details
- K-number
- K132397
- Device name
- GORE BIO-A WOUND MATRIX
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-01
- Decision date
- 2014-05-07
- Days to decision
- 279 days
- Clearance type
- Traditional
- Product code
- QSZ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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| Restrata® MiniMatrix (K223725) | Acera Surgical, Inc. | 2023-05-18 |
| SiOxD Wound Matrix (K222189) | Sioxmed, LLC | 2022-11-18 |
| NovoSorb Matrix (K221686) | Polynovo Biomaterials Pty, Ltd. | 2022-09-15 |
| Restrata® (K193583) | Acera Surgical, Inc. | 2020-09-25 |
| Phoenix Wound Matrix (K173544) | Nanofiber Solutions, Inc. | 2018-03-02 |
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| SupraSDRM Biodegradable Matrix Wound Dressing (K170213) | Polymedics Innovations, GmbH | 2017-06-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® VIABAHN® FORTEGRA Venous Stent (P250017) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S116) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S048) | W. L. Gore & Associates, Inc. | 2025-11-24 |
| GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S099) | W. L. Gore & Associates, Inc. | 2025-10-27 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S110) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S171) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S024) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S049) | W. L. Gore & Associates, Inc. | 2025-10-17 |