# K261658: LoFric Origo Pro Coudé

- Pathway: 510(k) (Special)
- Applicant: Wellspect AB
- Decided: Jul 17, 2026 after 59 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: 4 generations back to K896750 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250659: LoFric Origo, Wellspect AB (2025) Summary page 5.

## Indications for use
LoFric® Origo™ Pro Coudé is indicated for short- and long-term bladder management with intermittent urinary catheterization of adults and adolescents.

Source page: https://510kreport.com/device/K261658
Methodology: https://510kreport.com/methodology