# K043254: Pathway Ureteral Access Sheath, Pathway Expandable Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Onset Medical Corporation
- Decided: Feb 10, 2005 after 78 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) is intended to establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.

Source page: https://510kreport.com/device/K043254
Methodology: https://510kreport.com/methodology