510(k) · Cleared
ClearedIogyn 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
Cleared on Aug 29, 2014 as substantially equivalent to DEN130040 (Iogyn, Inc., 2014) after a 51-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.
- Decided
- Aug 29, 2014
- Review
- 51 days
- Class
- Class II
- Product code
- PGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130040 (2014). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130040 | Iogyn System | Iogyn, Inc. | 2014 | — |
| 0 (this device) | K141848 | Iogyn System | Iogyn, Inc. | 2014 | — |
| +1 | K233710 | Symphion Operative Hysteroscopy System | Minerva Surgical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN130040 | Iogyn System 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. | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233710 | Symphion Operative Hysteroscopy System | 2024 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K233710 (Minerva Surgical, Inc., 2024) has gone furthest, with 0 descendants 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141848: Iogyn System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141848
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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