Device |
percutaneous surgical set with attachments |
Regulation Description |
Manual percutaneous surgical set assembled in the abdomen. |
Definition |
Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues. |
Physical State |
A shaft plus end effector attachments with different sizes |
Technical Method |
A shaft of the device that can penetrate through soft tissue; attachments that will be delivered through a traditional conduit (such as a trocar) and assembled with the shaft inside the abdomen. |
Target Area |
Abdominal region |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | OXT |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4805
|
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 |