510(k) · Cleared
ClearedIogyn Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iogyn, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Mar 19, 2013 as substantially equivalent to K991563 (Henke Sass Wolf of America, Inc., 1999) and 1 other predicate after a 144-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 19, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954050 (1995). 6 ancestors in all, the oldest K953484 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954050 | Resectoscopes | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| −1 | K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode… | Henke Sass Wolf of America, Inc. | 1999 | — |
| 0 (this device) | K123330 | Iogyn Endoscope | Iogyn, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2009 | 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 HIH? 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 HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation…Summary page 1…IOGYN Endoscope Common Name: Endoscope Classification Name: 1-ysteroscope Predicate Device: o K991 563 - Hysteroscopic Resectoscope Device Description: The JOGYN Endoscope is a rigid multi-channel endoscope provided with… | 1999 |
| * | K082841 | Spinal ForaminoscopeSummary page 2…Subject Device Predicate Device Reference Device 510(k) No. Pending K991563 K082841 Device Endoscope Hysteroscopic Foraminoscope… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 13.4 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K991563.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, 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 | 1 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
What is it indicated for?
The IOGYN Endoscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. It is indicated for use in diagnostic examination and therapeutic surgical procedures of, but not limited to, urology and gynecology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123330 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123330: Iogyn Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123330
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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