# K243011: Silicone Urethral Catheter (Silicone Urethral Catheter)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Ecan Medical Co., Ltd.
- Decided: Jun 16, 2025 after 263 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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 K896053 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233094: Wellead® Latex Foley Catheter, Well Lead Medical (Hainan) Co., Ltd. (2024) Summary page 5.

## Indications for use
The Silicone Urethral Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine, or for routine post-operative drainage and bladder irrigation. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old).

Source page: https://510kreport.com/device/K243011
Methodology: https://510kreport.com/methodology