510(k) · Cleared
ClearedThe Gynocular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynius AB · HEX Colposcope (And Colpomicroscope)
Cleared on Apr 8, 2014 as substantially equivalent to K122973 (Medgyn Products, Inc., 2013) and 3 other predicates after a 246-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Apr 8, 2014
- Review
- 246 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K940094 (1995). 10 ancestors in all, the oldest K853389 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- 2 generations backK021153 Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Goldway Us, Inc. · 2003
- 1 generation backK122973 AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeMedgyn Products, Inc. · 2013
- This deviceK132423 The GynocularGynius AB · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| −2 | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 | Goldway Us, Inc. | 2003 | — |
| −1 | K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope | Medgyn Products, Inc. | 2013 | — |
| 0 (this device) | K132423 | The Gynocular | Gynius AB | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 HEX? 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 HEX device
- #1 K233043 Smart Scope® CXscore 8.4 · 4 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeSummary page 1…System Colposcope Model AL-i 06 IZM-31 0 AL 103 ColpoStar lH K-Number K122973 K031629 K880195 K853389 (4) Device Description Tlhe Gynocular is a hand-held, colposcope, which… | 2013 |
| * | K031639 | Intermed Zoom Colposcope Our reading of the summary gave K031629, FDA’s number for Canon Non-Mydriatic Retinal Camera, Model CR-Dgi (Canon USA, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “The Intermed Zoom Colposcope”. | 2003 |
| * | K880195 | GynescopeSummary page 1…Colposcope Model AL-i 06 IZM-31 0 AL 103 ColpoStar lH K-Number K122973 K031629 K880195 K853389 (4) Device Description Tlhe Gynocular is a hand-held, colposcope, which provides a magnified visualization of… | 1988 |
| * | K853389 | Wallach Zoom ColposcopeSummary page 1…lposcope Model AL-i 06 IZM-31 0 AL 103 ColpoStar lH K-Number K122973 K031629 K880195 K853389 (4) Device Description Tlhe Gynocular is a hand-held, colposcope, which provides a magnified visualization of the tissu… | 1985 |
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 19 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 10 ancestors has a recall.
- 4 other devices also cite its predicate K122973.
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HEX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HEX
165in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HEX
No recall names HEX since 2007.
Adverse event reports per year · HEX
1in 2025
MAUDE reports naming product code HEX, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 129 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 211 | 0 | 2 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 165 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Gynocular is intended to provide magnified visualization of the tissues of the vagina, cervix and external genitalia. It is used to evaluate these tissues and select areas for biopsy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132423: The Gynocular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132423
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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