Definition: For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair.
| Device Type ID | 5832 |
| Device Name | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Physical State | An Absorbable Mesh; Either Square, Rectangular, Round Or Of Various Other Shapes. |
| Technical Method | An Absorbable Mesh That Reinforces Soft Tissue |
| Target Area | Including But Not Limited To Abdominal, Inguinal, Femoral, Umbilical, And Incisional Hernias. |
| 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 | OWT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5832 |
| Device | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Product Code | OWT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NOVUS SCIENTIFIC AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 35 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Defective Device | 1 |
Break | 1 |
Material Deformation | 1 |
Material Fragmentation | 1 |
Hole In Material | 1 |
Material Too Rigid Or Stiff | 1 |
Migration Or Expulsion Of Device | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 46 |