PIJ · Collagen Surgical Mesh Containing Drugs
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | PIJ |
|---|---|
| Device Name | Collagen Surgical Mesh Containing Drugs |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162193 | XenMatrix AB Surgical Graft | C. R. Bard | Dec 23, 2016 | SESE |
| K151177 | XenMatrix AB Surgical Graft | C. R. Bard | Jul 30, 2015 | SESE |
| K133223 | XENMATRIX AB SURGICAL GRAFT | C.R. Bard, Inc. | Sep 19, 2014 | SESE |
Top Applicants
- C. R. Bard — 2 clearances
- C.R. Bard, Inc. — 1 clearance
