Definition: For Reinforcement Of Soft Tissue Where Weakness Exists In Abdominal Wall Defects.
| Device Type ID | 5849 |
| Device Name | Mesh, Surgical, Collagen, Large Abdominal Wall Defects |
| Physical State | A Collagen Mesh; Either Square, Rectangular, Round Or Of Various Other Shapes |
| Technical Method | A Collagen Mesh That Reinforces Soft Tissue |
| Target Area | Abdominal Wall |
| Regulation Description | Surgical Mesh. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OXK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5849 |
| Device | Mesh, Surgical, Collagen, Large Abdominal Wall Defects |
| Product Code | OXK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Degraded | 4 |
None | 1 |
Torn Material | 1 |
Insufficient Information | 1 |
| Total Device Problems | 11 |