Product code PGT— Obstetrics/Gynecology

IOGYN SYSTEM

Classification name: Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
Device class: Class 2
Regulation: 21 CFR 884.1710
Advisory panel: Obstetrics/Gynecology
Total cleared: 3
First cleared: 2014-03-28
Most recent: 2024-01-17

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.”
— U.S. Food and Drug Administration, device classification record for product code PGT under 21 CFR 884.1710, via openFDA

Market context for product code PGT

FDA has cleared 3 devices under product code PGT between 2014 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20241 clearance
20142 clearances

Top applicants under product code PGT

Iogyn, Inc.2 clearances
Minerva Surgical, Inc.1 clearance

Recent clearances under product code PGT

K233710 — Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.·2024-01-17
K141848 — IOGYN SYSTEMIogyn, Inc.·2014-08-29
DEN130040 — IOGYN SYSTEMIogyn, Inc.·2014-03-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.