K001789 is an FDA 510(k) clearance for the SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL. This device is classified as a Mesh, Surgical, Non-absorbable, Staple Line Reinforcement (Class II - Special Controls, product code OXD).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on July 6, 2000, 23 days after receiving the submission on June 13, 2000.
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 | K001789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2000 |
| Decision Date | July 06, 2000 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OXD — Mesh, Surgical, Non-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. |