# K051059: Amsure 100% Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Jun 28, 2005 after 63 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K062240: Carevent (2006), 0 descendants of its own

## Indications for use
The AMSure 100% Silicone Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract

Source page: https://510kreport.com/device/K051059
Methodology: https://510kreport.com/methodology