Definition: Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Soft Tissue Defects (e.G. Hernia Repair).
| Device Type ID | 5824 |
| Device Name | Mesh, Surgical, Deployer |
| Physical State | Manual Laparoscopic Surgical Instrument ;operation Handle And Deployment Section. |
| Technical Method | Intended To Facilitate Hernia Mesh Delivery And Placement During Laparoscopic Ventral Hernia Repair. |
| Target Area | Abdominal Cavity |
| 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 | ORQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5824 |
| Device | Mesh, Surgical, Deployer |
| Product Code | ORQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Device Problems | |
|---|---|
Misfire | 9 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Failure To Form Staple | 3 |
Entrapment Of Device | 2 |
Material Rupture | 1 |
Break | 1 |
Fluid Leak | 1 |
Device Slipped | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Expulsion | 1 |
Leak / Splash | 1 |
| Total Device Problems | 25 |