# K143650: CooperSurgical Advincula Delineator Uterine Manipulator

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Jul 21, 2015 after 210 days
- Product code: HEW (Culdoscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954311 (1996). 1 ancestor in all.
2 later devices descend 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)
- K954311: Koh Colpotomizer System, CooperSurgical, Inc. (1996) Summary page 4.

## Most influential descendants
- K180429: Advincula Delineator Uterine Manipulator (2018), 1 descendant of its own
- K201086: Advincula Delineator Uterine Manipulator (2020), 0 descendants of its own

## 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 Supra-Cervical Hysterectomy (LSH).

Source page: https://510kreport.com/device/K143650
Methodology: https://510kreport.com/methodology