# K223064: ALLY II Uterine Positioning System™ (UPS)

- Pathway: 510(k) (Special)
- Applicant: CooperSurgical, Inc.
- Decided: Oct 28, 2022 after 28 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 K941458 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141523: Ally Ups, CooperSurgical, Inc. (2014) Summary page 4.

## Indications for use
The ALLY II UPS™ (Uterine Positioning System) is intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.

Source page: https://510kreport.com/device/K223064
Methodology: https://510kreport.com/methodology