GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER— 510(k) K042427

Name: FDA 510(k) clearance K042427
Creator: U.S. Food and Drug Administration
Published: 2004-12-03

Substantially Equivalent

Genemed, Inc.

FDA 510(k) clearance K042427 for GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, Substantially Equivalent on 2004-12-03. Applicant: Genemed, Inc.. Device class: 2.

Clearance details

Applicant: Genemed, Inc.
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2004-09-08
Decision date: 2004-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Woodbury, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNS

view all

K261086 — Break Wave2026-04-29
K252913 — Break Wave2026-01-12
K242922 — Extracorporeal Shock Wave Lithotripter (U200)2025-06-18
K221903 — Delta III Pro2023-02-22
K213772 — LM-9300 Plus Lithotripter2023-01-19

More clearances from Genemed, Inc.

view all

K943479 — GENEMED YAG 1000 MEDICAL LASER1994-09-29

Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.