| Device |
insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar |
| Regulation Description |
Closed loop hysteroscopic insufflator with cutter-coagulator. |
| Definition |
to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy. It is also intended for cutting and coagulation of uterine tissue. |
| Physical State |
controller that provides bipolar frequency and fluid management through the use of two peristaltic pumps. Bipolar frequency is delivered to a bipolar electrosurgical resection device. Fluid management is provided via infusion/aspiration through tubing, sensors, tissue collection container and filter. |
| Technical Method |
a closed-loop system with a preset volume of saline available for use during hysteroscopy. Fluid is continuously recirculated by pumps from a 3L saline bag, into the uterus, through a tissue trap and a filter and then back to the bag. Cutting and coagulation are accomplished through use of a bipolar device that has a reciprocating loop electrode. |
| Target Area |
uterus |
| Regulation Medical Specialty |
Obstetrics/Gynecology |
| Review Panel |
Obstetrics/Gynecology |
|---|
| Product Code | PGT |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
884.1710
|
|---|
| 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 |
