PGT

Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

Product code

PGT

Device name

Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

Device class

Class 2

21 CFR

21 CFR 884.1710

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-01-17.

1 summaries are archived here for direct download.