510(k) · Cleared
ClearedCooper Surgical Leisegang Colposcope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · HEX Colposcope (And Colpomicroscope)
Cleared on Oct 23, 2014 as substantially equivalent to K940094 (Leisegang Medical, Inc., 1995) and 2 other predicates after a 211-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Oct 23, 2014
- Review
- 211 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K940094 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK140754 Cooper Surgical Leisegang Colposcope SystemCooperSurgical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK160341 Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2016 · cites it directly0descendants
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) | K140754 | Cooper Surgical Leisegang Colposcope System | CooperSurgical, Inc. | 2014 | — |
| +1 | K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K940094 | Colposcopes and AccessoriesSummary page 4…CFR Section: 21 CFR 884.1630 PREDICATE DEVICE(S): Leisegang Colposcope(s), K940094, Galileo Corp. Leisegang Video Colposcope,… | 1995 |
| * | K981958 | Leisegang Video ColposcopeSummary page 4…K940094, Galileo Corp. Leisegang Video Colposcope, K981958, MedGyn Products, Inc. Digital Video Colposcope,… | 1998 |
| * | K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeSummary page 4…K981958, MedGyn Products, Inc. Digital Video Colposcope, K122973. DEVICE DESCRIPTION: The Cooper Surgical Leisegang Colposcope(s) and accessories are optical colposcopes designed for non-cont… | 2013 |
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 |
|---|---|---|---|
| K160341 | Colposcope System | 2016 | 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?
- 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 6 ancestors has a recall.
- Of its descendants, K160341 (Xuzhou Kernel Medical Equipment Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K940094.
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 Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from Cooper Surgical Leisegang Colposcopes may be viewed directly and/or on a color monitor (if so equipped). Cooper Surgical Leisegang Colposcopes are intended for use in hospitals, clinics, and doctor’s offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140754: Cooper Surgical Leisegang Colposcope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140754
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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