# K260999: LoFric Elle Pro

- Pathway: 510(k) (Special)
- Applicant: Wellspect AB
- Decided: Apr 24, 2026 after 29 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K123751 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211212: LoFric Elle, Dentsply Sirona (2022) Summary page 5.

## Indications for use
LoFric Elle Pro is intended for intermittent urinary catheterization

Source page: https://510kreport.com/device/K260999
Methodology: https://510kreport.com/methodology