# K240364: RELIEEV Uterine Manipulator Injector (CUMI 5.0)

- Pathway: 510(k) (Traditional)
- Applicant: Li Medical Corporation, Ltd.
- Decided: Oct 16, 2024 after 253 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: 1 generation back to K092980 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092980: Panpac Uterine Manipulator Injector, Model Umi 4.5, Panpac Medical Corporation (2010) Summary page 5.

## Indications for use
Use of the RELIEEV Uterine Manipulator Injector is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty procedures where manipulation of the uterus is required.

Source page: https://510kreport.com/device/K240364
Methodology: https://510kreport.com/methodology