• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
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 CodePGT
Premarket Review 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible