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 Iogyn, Inc. and 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
Cleared Aug 29, 2014
IOGYN SYSTEM
K141848
Iogyn, Inc.
Obstetrics & Gynecology · 51d
Not Cleared Mar 28, 2014
IOGYN SYSTEM
DEN130040
Iogyn, Inc.
Obstetrics & Gynecology · 210d

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.