# K092980: Panpac Uterine Manipulator Injector, Model Umi 4.5

- Pathway: 510(k) (Traditional)
- Applicant: Panpac Medical Corporation
- Decided: Mar 11, 2010 after 164 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K240364: RELIEEV Uterine Manipulator Injector (CUMI 5.0) (2024), 0 descendants of its own
- K212505: DUMI ManipulatOR (2022), 0 descendants of its own

## Indications for use
This Uterine Manipulator Injector (Model UMI-4.5) is indicated for use in Diagnostic Laparotomy, Minilaparotomy, Pelvic Examinations, and Salpingoplastic procedures where manipulation of the uterus is required: This product also facilitates the sealing of cervical os while providing a fluid injection port.

Source page: https://510kreport.com/device/K092980
Methodology: https://510kreport.com/methodology