XenX Stone Management Device

by Xenolith Medical

510(k) K123438

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K123438↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK123438	Date10 Jan 2013Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K123438
FDA Product Code: OCY

Device Class: Class II
Regulation: 21 CFR Part 876.1500
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The XenX Stone Management Device is an endoscopic guidewire designed for the retrieval of urinary stones. It combines a nitinol core wire with a self-expanding braided nitinol mesh and a hydrophilic, polyurethane-coated tip to facilitate navigation and secure stone capture during urological procedures.

This device is intended for single-use in clinical settings and is classified as a Class II medical device under FDA regulations. Supplied sterile, it is used in conjunction with endoscopic techniques to manage and remove stones within the urinary tract. The device’s design includes a 7cm tip length variant, as referenced in regulatory filings, and adheres to FDA 510(k) clearance (K123438) for gastroenterology and urology applications.

Other devices from Xenolith Medical

Xenx

Class II