PGT · Class II · 21 CFR 884.1710

FDA Product Code PGT: Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar

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.

Leading manufacturers include Minerva Surgical, Inc..

3
Total
2
Cleared
106d
Avg days
2014
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar Devices (Product Code PGT)

3 devices
1–3 of 3
Cleared Jan 17, 2024
Symphion Operative Hysteroscopy System
K233710
Minerva Surgical, Inc.
Obstetrics & Gynecology · 58d

About Product Code PGT - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code PGT since 2014, with 2 receiving FDA clearance (average review time: 106 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

PGT devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →