| Device |
gynecologic power morcellator and containment system |
| Definition |
A gynecologic power morcellator and containment system is a prescription device consisting of an integrated power morcellator and a containment method that are intended to contain, reduce and remove gynecologic tissue that is not suspected to contain malignancy during minimally invasive surgery. |
| Physical State |
Integrated system consisting of a power morcellator and containment system. The tissue container is a large bag with a single opening. The power morcellator is a handheld cutting tool which allows visualization and tissue extraction through the inner diameter of the cutting blade. The two components are electrically powered/connected with a console. |
| Technical Method |
Uterine tissue is placed laparoscopically within the containment system. The integrated power morcellator is used within the containment system to reduce the tissue specimen and remove it through a minimally invasive incision or natural orifice. |
| Target Area |
Peritoneum, uterus, and/or vagina |
| Regulation Medical Specialty |
Obstetrics/Gynecology |
| Review Panel |
Obstetrics/Gynecology |
|---|
| Product Code | SIM |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
884.4075
|
|---|
| 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 |
