# K023051: Intrauterine Delivery System - Injector

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Dec 12, 2002 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Intrauterine delivery system is used to deliver and fill uterine cavity with sterile imaging agents or injection media for ultrasound imaging, diagnosis and treatment of uterine cavity and uterine disorders. The injection media /agents can be saline, contrast agents, or other sonography media / agents in liquid, viscous gel or suspension form to conform the interior of the uterine cavity. The Uterine delivery catheter device is designed to facilitate the sealing of the cervical os during injection procedure.

Source page: https://510kreport.com/device/K023051
Methodology: https://510kreport.com/methodology