# DEN130040: Iogyn System

- Pathway: De Novo (Direct)
- Applicant: Iogyn, Inc.
- Decided: Mar 28, 2014 after 210 days
- Product code: PGT (Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar)
- Device class: 2
- Regulation: 21 CFR 884.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K141848: Iogyn System (2014), 1 descendant of its own
- K233710: Symphion Operative Hysteroscopy System (2024), 0 descendants of its own

## Indications for use
The IOGYN System, a prescription device under 21 CFR Part 801.109 that is indicated for distension of the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed loop recirculation of filtered distension fluid. It is also intended for cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.

Source page: https://510kreport.com/device/DEN130040
Methodology: https://510kreport.com/methodology