OXE · Mesh, Surgical, Collagen, Staple Line Reinforcement
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OXE |
|---|---|
| Device Name | Mesh, Surgical, Collagen, Staple Line Reinforcement |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170945 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | Apr 28, 2017 | SESE |
| K153364 | Kerecis SecureMesh | Kerecis Limited | Aug 19, 2016 | SESE |
| K030879 | VERITAS COLLAGEN MATRIX | Synovis Surgical Innovations | Apr 24, 2003 | SESE |
| K022044 | SURGISIS STAPLE LINE REINFORCEMENT | Cook Biotech, Inc. | Aug 23, 2002 | SESE |
Top Applicants
- Synovis Surgical Innovations — 1 clearance
- Kerecis Limited — 1 clearance
- Cook Biotech, Inc. — 1 clearance
- Cook Biotech Incorporated — 1 clearance
