# K153092: Ally Uterine Positioning System

- Pathway: 510(k) (Special)
- Applicant: CooperSurgical, Inc.
- Decided: Dec 21, 2015 after 56 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
Ally Uterine Positioning System™ The Ally Uterine Positioning System™ (UPS) 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. Adapter Drape for the Ally UPS System The Advincula Delineator™ Adapter Drape for the Ally Uterine Positioning System™ UPS 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/K153092
Methodology: https://510kreport.com/methodology