K131658 is an FDA 510(k) clearance for the GORE SEAMGUARD REINFORCEMENT. This device is classified as a Mesh, Surgical, Absorbable, Staple Line Reinforcement (Class II - Special Controls, product code OXC).
Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on September 6, 2013, 92 days after receiving the submission on June 6, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures..
| 510(k) Number | K131658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2013 |
| Decision Date | September 06, 2013 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXC — Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures. |