Definition: The Device Is Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Hernias.
| Device Type ID | 5821 |
| Device Name | Mesh, Surgical, Deployment Balloon |
| Physical State | The Device Is Comprised Of Three Main Components: An Inflatable Spreading Balloon, An Adaptor, And An Inflation Unit/pump. |
| Technical Method | The Device Is Reversibly Attached To Soft Tissue Prosthetics, Such As Surgical Mesh, Through The Use Of Connectors, Before Being Rolled For Insertion Into The Body. Once Located In The Abdominal Cavity, The Device Is Spread At The Desired Location By |
| 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 | OQL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5821 |
| Device | Mesh, Surgical, Deployment Balloon |
| Product Code | OQL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |