# K180429: Advincula Delineator Uterine Manipulator

- Pathway: 510(k) (Special)
- Applicant: CooperSurgical, Inc.
- Decided: Mar 14, 2018 after 26 days
- Product code: HEW (Culdoscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954311 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143650: CooperSurgical Advincula Delineator Uterine Manipulator, CooperSurgical, Inc. (2015) Summary page 4.

## Most influential descendants
- K201086: Advincula Delineator Uterine Manipulator (2020), 0 descendants of its own

## Recalls of this device
- Jun 14, 2019 · Class II · Z-1977-2019: 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 la
- Jun 14, 2019 · Class II · Z-1978-2019: 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 la

## Indications for use
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).

Source page: https://510kreport.com/device/K180429
Methodology: https://510kreport.com/methodology