PGT — Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar Class II

FDA Device Classification

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233710minerva surgicalSymphion Operative Hysteroscopy SystemJanuary 17, 2024
K141848iogynIOGYN SYSTEMAugust 29, 2014
DEN130040iogynIOGYN SYSTEMMarch 28, 2014