# K161065: ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator

- Pathway: 510(k) (Traditional)
- Applicant: Surgitools Pty, Ltd.
- Decided: Oct 27, 2016 after 195 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: 2 generations back to K954311 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110819: Singhmed Roolip Manipulator, J.Singh Instruments (2011) Summary page 4.

## Indications for use
The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation and visualization of the position of the vaginal fornices for colpotomy incisions is required, and for maintaining pneumoperitoneum during vaginal vault closure.

Source page: https://510kreport.com/device/K161065
Methodology: https://510kreport.com/methodology