Device |
mesh, surgical, deployer |
Regulation Description |
Surgical mesh. |
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). |
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 Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | ORQ |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
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 |