| Device |
containment system, laparoscopic power morcellation, with instrument port |
| Regulation Description |
Gynecologic laparoscopic power morcellation containment system. |
| Definition |
Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The device is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation. |
| 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 resected gynecologic 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 |
Obstetrics/Gynecology |
| Review Panel |
Obstetrics/Gynecology |
|---|
| Product Code | PMU |
|---|
| Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
884.4050
|
|---|
| 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 |
