Definition: For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.
| Device Type ID | 5844 |
| Device Name | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| Physical State | An Absorbable Mesh; Either Square, Round, Rectangular Or Of Various Other Shapes. |
| Technical Method | An Absorbable Mesh That Reinforces Soft Tissue |
| Target Area | An Area In Need Of Plastic And Reconstructive Surgery |
| 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 | OXF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5844 |
| Device | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| Product Code | OXF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
W.L. GORE & ASSOCIATES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
W.L. GORE & ASSOCIATES,INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 173 |
Appropriate Term/Code Not Available | 105 |
Patient-Device Incompatibility | 61 |
Material Disintegration | 11 |
Insufficient Information | 3 |
Difficult To Remove | 2 |
Contamination During Use | 2 |
Use Of Device Problem | 2 |
Deformation Due To Compressive Stress | 2 |
No Apparent Adverse Event | 1 |
Migration | 1 |
Migration Or Expulsion Of Device | 1 |
Folded | 1 |
| Total Device Problems | 365 |