# K123438: Xenx Stone Management Device

- Pathway: 510(k) (Special)
- Applicant: Xenolith Medical
- Decided: Jan 10, 2013 after 63 days
- Product code: OCY (Endoscopic Guidewire, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy and to facilitate the placement of endourolagical instruments during diagnostic or interventional procedures.

Source page: https://510kreport.com/device/K123438
Methodology: https://510kreport.com/methodology