GORE SEAMGUARD Reinforcement
FDA 510(k) clearance K150551 · decided 2015-03-30
Clearance details
- K-number
- K150551
- Device name
- GORE SEAMGUARD Reinforcement
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-04
- Decision date
- 2015-03-30
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- OXC
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Flagstaff, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (K252906) | Ethicon Endo-Surgery, LLC | 2026-01-09 |
| Standard Staple-Line Reinforcement (SSLR23) (K231603) | Standard Bariatrics, Inc. | 2023-10-06 |
| ECHELON ENDOPATH Staple Line Reinforcement (K221343) | Ethicon Endo-Surgery, LLC | 2022-09-16 |
| NEOVEIL Staple Line Reinforcement (K221487) | Gunze Limited | 2022-08-26 |
| Echelon Endopath Staple Line Reinforcement (K190937) | Ethicon Endo-Surgery, LLC | 2019-10-14 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| NEOVEIL (K130997) | Gunze Limited | 2013-11-15 |
| GORE SEAMGUARD REINFORCEMENT (K131658) | W. L. Gore & Associates, Inc. | 2013-09-06 |
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 |