# K113692: XENX

- Pathway: 510(k) (Traditional)
- Applicant: Xenolith Medical
- Decided: Aug 9, 2012 after 238 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
Longest line of descent: 2 generations back to K871777 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082536: Cook Wire Guides, Cook Urological, Inc. (2008) Summary page 2.
- K970121: Stone Dislodger, Basket, Boston Scientific Corp (1997) Summary page 2.
- K052048: Accordion, Percutaneous Systems, Incorporated (2005) Summary page 2.
- K863081: 4-Wire (Carson) Stone Extractor, Cook Urological, Inc. (1986) Summary page 2.
- (no number) Sensor Nitinol Guidewire: named in the summary without a submission number

## 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 endourological instruments during diagnostic or interventional procedures.

Source page: https://510kreport.com/device/K113692
Methodology: https://510kreport.com/methodology