# K061009: Pathway Balloon Expandable Ureteral Access Sheath, Model Beus

- Pathway: 510(k) (Special)
- Applicant: Onset Medical Corporation
- Decided: May 2, 2006 after 20 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- Recalls of this device: 9 (0 Class I)
- 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.

## Recalls of this device
- Nov 30, 2007 · Not classified · Z-0905-2008: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Nov 30, 2007 · Not classified · Z-0909-2008: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Nov 30, 2007 · Not classified · Z-0912-2008: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Nov 30, 2007 · Not classified · Z-0913-2008: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Nov 30, 2007 · Not classified · Z-0906-2008: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Nov 30, 2007 · Not classified · Z-0907-2008: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Nov 30, 2007 · Not classified · Z-0908-2008: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Nov 30, 2007 · Not classified · Z-0911-2008: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Nov 30, 2007 · Not classified · Z-0910-2008: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

## Indications for use
The Onset Medical Pathway TM Balloon Expandable Ureteral Access 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/K061009
Methodology: https://510kreport.com/methodology