| Device |
mesh, surgical, deployment balloon |
| Regulation Description |
Surgical mesh. |
| Definition |
The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias. |
| 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 inflating it using an external inflation pump. |
| Target Area |
Abdominal cavity. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OQL |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.3300
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
