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Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter

by Genemed, Inc.

510(k) K042427

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK042427 Date3 Dec 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNS
Device Class
Class II
Regulation
21 CFR Part 876.5990
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary stones. The Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter generates focused acoustic energy to fragment renal and upper ureteral calculi.

It is operated by trained medical professionals in clinical settings for the non-invasive fragmentation of kidney (renal pelvis and renal calyceal) and upper ureteral stones between 5 and 20 mm in size. The device is supplied as a reusable system and has received FDA 510(k) clearance under k-number K042427, with product code LNS and regulation number 876.5990.

Other devices from Genemed, Inc.

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter used for?

    It is used for the non-invasive fragmentation of kidney stones located in the renal pelvis and renal calyceal system, as well as upper ureteral stones, specifically those measuring between 5 and 20 mm in size. This is achieved by focusing ultrasonic shock waves to break down calculi without surgery.

  • How is the Genestone Exel (XL) supplied and is it reusable or single-use?

    The device is supplied as a reusable system, meaning it is designed for multiple uses after proper cleaning and maintenance between procedures. It is not a single-use disposable device and requires trained medical professionals to operate it in clinical settings.

  • What regulatory clearance does the Genestone Exel (XL) have and what is its k-number?

    The Genestone Exel (XL) has received FDA 510(k) clearance, which means it was found substantially equivalent to a legally marketed predicate device. Its specific k-number is K042427, and it was cleared under product code LNS and regulation number 876.5990.