510(k) · Cleared
ClearedGynescope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Illumigyn, Ltd. · HEX Colposcope (And Colpomicroscope)
Cleared on May 8, 2019 as substantially equivalent to K122973 (Medgyn Products, Inc., 2013) after a 96-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 8, 2019
- Review
- 96 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940094 (1995). 5 ancestors in all. 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 deviceK190187 Gynescope SystemIllumigyn, Ltd. · 2019
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) | K190187 | Gynescope System | Illumigyn, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeSummary page 4…tory Class: Class II Predicate Device: MedGyn Digital Video Colposcope MedGyn Products, Inc. 510(k) Number – K122973 The predicate device has not been subject to a design-related recall. Device Description: The Gynescope™ System is a colposcop… | 2013 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 5 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. 2019, 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 Gynescope™ System is intended for the examination of the tissues of the vagina, cervix, and external genitalia, to investigate, by means of magnification, abnormalities such as lesions or cancer. The Gynescope™ System is intended to select areas for biopsy, when indicated.
The Gynescope™ Single Use Vaginal Speculum component of the Gynescope™ System is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The Gynescope™ Single Use Vaginal Speculum can be used only with the Gynescope™ System.
The Gynescope™ System is intended for use in hospitals, clinics, and doctors' offices.
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/K190187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190187: Gynescope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190187
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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