De Novo · Granted
GrantedIogyn System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iogyn, Inc. · PGT Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
Granted on Mar 28, 2014 as a new device type through De Novo after a 210-day review. 2 later devices descend from it.
- Decided
- Mar 28, 2014
- Review
- 210 days
- Class
- Class II
- Product code
- PGT
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130040 | Iogyn System | Iogyn, Inc. | 2014 | — |
| +1 | K141848 | Iogyn System | Iogyn, Inc. | 2014 | — |
| +2 | K233710 | Symphion Operative Hysteroscopy System | Minerva Surgical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGT device
- #1 K233710 Symphion Operative Hysteroscopy Systemscore 8.8 · 8 generations · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141848 | Iogyn System | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K141848 (Iogyn, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PGT devicesPGT Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PGT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PGT
Too few PGT 510(k)s in any year since 2007 to give a median.
Recalls per year · PGT
No recall names PGT since 2007.
Adverse event reports per year · PGT
1in 2025
MAUDE reports naming product code PGT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 39 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN130040 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130040: Iogyn System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130040
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026