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
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.