PGT — Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar Class II
FDA product code PGT covers "Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar", a Class II medical device regulated under 21 CFR 884.1710. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PGT
- Device Class
- Class II
- Regulation Number
- 884.1710
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.