# K201086: Advincula Delineator Uterine Manipulator

- Pathway: 510(k) (Special)
- Applicant: CooperSurgical, Inc.
- Decided: May 21, 2020 after 28 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: 3 generations back to K954311 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180429: Advincula Delineator Uterine Manipulator, CooperSurgical, Inc. (2018) Summary page 4.

## 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, Laparoscopic Assisted Vaginal Hysterectomy and/or Laparoscopic Supra-Cervical Hysterectomy.

Source page: https://510kreport.com/device/K201086
Methodology: https://510kreport.com/methodology