510(k) K053200 ยท FTL Mesh, Surgical, Polymeric
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Dec 7, 2005 |
| Received | Nov 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2024 | W.L. Gore & Associates, Inc. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25; Open, Classified |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.