510(k) · Cleared
ClearedCoopersurgical Digital Colposcopy 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 Feb 2, 1998 as substantially equivalent to K940094 (Leisegang Medical, Inc., 1995) and 1 other predicate after a 203-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Feb 2, 1998
- Review
- 203 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940094 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K092433DYSISForth Photonics Hellas SA · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| 0 (this device) | K972630 | Coopersurgical Digital Colposcopy System | CooperSurgical, Inc. | 1998 | — |
| +1 | K092433 | DYSIS | Forth Photonics Hellas SA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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 |
|---|---|---|---|
| * | K940094 | Colposcopes and AccessoriesSummary page 2…cal, Inc., and the Model 88000 and 89000 Video Colposcopes, manufactured by Welch Allyn, Inc. The Leisegang device received 510(k) premarket notification clearance under K940094 while the Welch Allyn devices were cleared under K955635. The CooperSurgical, Leisegang and Welch Allyn colposcopes are all inte… | 1995 |
| * | K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm StandSummary page 2…s, manufactured by Welch Allyn, Inc. The Leisegang device received 510(k) premarket notification clearance under K940094 while the Welch Allyn devices were cleared under K955635. The CooperSurgical, Leisegang and Welch Allyn colposcopes are all intended to permit direct viewing and imaging of the tissues… | 1996 |
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 |
|---|---|---|---|
| K092433 | DYSIS | 2011 | 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?
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CooperSurgical Digital Colposcopy System combines a standard colposcope with a computer-based Digital Documentation System. The colposcope is intended to permit direct magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Digital Documentation System is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color monitor, printed on a color printer, or archived for storage and subsequent retrieval.
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/K972630 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972630: Coopersurgical Digital Colposcopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972630
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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