K150551 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. (Flagstaff, US). The FDA issued a Cleared decision on March 30, 2015, 26 days after receiving the submission on March 4, 2015.
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 | K150551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2015 |
| Decision Date | March 30, 2015 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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. |