# K141848: Iogyn System

- Pathway: 510(k) (Special)
- Applicant: Iogyn, Inc.
- Decided: Aug 29, 2014 after 51 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
Longest line of descent: 1 generation back to DEN130040 (2014). 1 ancestor in all.
1 later device descends 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)
- DEN130040: Iogyn System, Iogyn, Inc. (2014). Our reading of the summary gave K132695, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130040, Iogyn System (Iogyn, Inc.), granted Mar 28, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K233710: Symphion Operative Hysteroscopy System (2024), 0 descendants of its own

## Indications for use
The IOGYN System is intended to distend 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/K141848
Methodology: https://510kreport.com/methodology