MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Device Facts
| Record ID | K010936 |
|---|---|
| Device Name | MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL |
| Applicant | W. L. Gore & Associates, Inc. |
| Product Code | OXD · General, Plastic Surgery |
| Decision Date | May 21, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
