Device |
mesh, surgical, absorbable, staple line reinforcement |
Regulation Description |
Surgical mesh. |
Definition |
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures. |
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 |
Areas in need of sutures |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | OXC |
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? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |