510(k) · Cleared
Recalled · Class II · 2019Advincula Delineator Uterine Manipulator
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 Mar 14, 2018 as substantially equivalent to K143650 (CooperSurgical, Inc., 2015) after a 26-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 14, 2018
- Review
- 26 days
- Class
- Class II
- Product code
- HEW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954311 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK954311 Koh Colpotomizer SystemCooperSurgical, Inc. · 1996 · Recalled
- 1 generation backK143650 CooperSurgical Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. · 2015
- This deviceK180429 Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK201086 Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201086Advincula Delineator Uterine ManipulatorCooperSurgical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954311 | Koh Colpotomizer System | CooperSurgical, Inc. | 1996 | 2 |
| −1 | K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2015 | — |
| 0 (this device) | K180429 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2018 | — |
| +1 | K201086 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (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 |
|---|---|---|---|
| * | K143650 | CooperSurgical Advincula Delineator Uterine ManipulatorSummary page 4…ncula Delineator uterine manipulator is substantially equivalent to the following predicates: Predicate: CooperSurgical Advincula Delineator Uterine Manipulator (K143650) The predicate device has not been subject to a design-related recall. Device Description The Advincula Delineator is a uterin… | 2015 |
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 |
|---|---|---|---|
| K201086 | Advincula Delineator Uterine Manipulator | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2019 | Class II | Z-1977-2019 | Under Investigation by firm | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations. |
| Jun 14, 2019 | Class II | Z-1978-2019 | Under Investigation by firm | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 1 company; a new generation was cleared every 18.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K201086 (CooperSurgical, Inc., 2020) has gone furthest, with 0 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. 2018, this device’s year, is highlighted.
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 CooperSurgical Advincula Delineator Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supracervical Hysterectomy (LSH).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180429 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180429: Advincula Delineator Uterine Manipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180429
Report an extraction error
Are you the manufacturer?
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