510(k) · Cleared
Recalled · Class II · 2021Koh Colpotomizer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · HEW Culdoscope (And Accessories)
Cleared on Nov 19, 1996 after a 431-day review. The FDA summary names its predicate without a number. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 19, 1996
- Review
- 431 days
- Class
- Class II
- Product code
- HEW
- Recalls
- 2
- Predicates
- 0
13 later devices descend from it, 6 citing it directly.
- This deviceK954311 Koh Colpotomizer SystemCooperSurgical, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK051594 Mccartney Access TubeGynetech Pty., Ltd. · 2005
- Descendant · 2 generations on · 2 of its ownK143308 GelPOINT Transvaginal Access PlatformApplied Medical Resources · 2015
- Descendant · cites it directly · 2 of its ownK143650 CooperSurgical Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK191294 Transvaginal Access PlatformApplied Medical Resources Corp. · 2019
- Descendant · 2 generations on · 1 of its ownK180429 Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. · 2018 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K051594Mccartney Access TubeGynetech Pty., Ltd. · 2005 · cites it directly3descendants
- K143308GelPOINT Transvaginal Access PlatformApplied Medical Resources · 2015 · 2 generations on2descendants
- K143650CooperSurgical Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. · 2015 · cites it directly2descendants
- K191294Transvaginal Access PlatformApplied Medical Resources Corp. · 2019 · 3 generations on1descendant
- K180429Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954311 | Koh Colpotomizer System | CooperSurgical, Inc. | 1996 | — |
| +1 | K051594 | Mccartney Access Tube | Gynetech Pty., Ltd. | 2005 | — |
| +2 | K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | 2015 | — |
| +1 | K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2015 | — |
| +3 | K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | 2019 | — |
| +2 | K180429 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2018 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 HEW? 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 HEW device
- #1 K243152 GelPOINT V-Path Transvaginal Access Platform…score 11.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | — | Lubke Uterine Vacuum Cannula Named without a submission number | |
| * | — | SEMM Uterine Vacuum Cannula Named without a submission number | |
| * | — | Milex Inflato Ball Named without a submission number |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2021 | Class II | Z-1686-2021 | Labeling design | The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required. |
| Sep 4, 2018 | Class II | Z-0098-2019 | Other | The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051594 (Gynetech Pty., Ltd., 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HEW devicesHEW Culdoscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HEW
Too few HEW 510(k)s in any year since 2007 to give a median.
Recalls per year · HEW
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HEW
20in 2025
MAUDE reports naming product code HEW, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 1 | — | 1 | 14 |
| 2019 | 1 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 35 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 20 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Koh Colpotomizer™ System, comprised of the Koh Cup™ Vaginal Fornices Delineator and Colpo-Pneumo Occluder, are accessories to the RUMI uterine manipulator, K932115. These accessories are designed to attach to the RUMI uterine manipulator device and are intended to be used by the surgeon as an anatomical marker to locate the position of the vaginal fornices as viewed through uterine tissue from within the abdominal cavity (intracorporeal), and also to maintain pneumoperitoneum during laparoscopic surgical procedures in which a colpotomy or culdotomy incision is made. The Koh Colpotomizer™ System is used in conjunction with the RUMI uterine manipulator device.
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/K954311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954311: Koh Colpotomizer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954311
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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