| Device |
general laparoscopic power morcellation containment system |
| Regulation Description |
General laparoscopic power morcellation containment system. |
| Definition |
Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. |
| Physical State |
A retractor and boot assembly with a tissue pouch/specimen bag. |
| Technical Method |
A tissue pouch is placed through a multi-instrument port to allow for containment of tissue. The pouch is insufflated to create a working space for morcellation. A laparoscopic power morcellator and a laparoscope are placed through the port and into the pouch to enable visualization of the morcellation. |
| Target Area |
Abdomen |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | PZQ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4825
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
