SONOLITH I-SYS LITHOTRIPER— 510(k) K083614

Name: FDA 510(k) clearance K083614
Creator: U.S. Food and Drug Administration
Published: 2009-07-27

Substantially Equivalent

Technomed Medical Systems, SA

FDA 510(k) clearance K083614 for SONOLITH I-SYS LITHOTRIPER, Substantially Equivalent on 2009-07-27. Applicant: Technomed Medical Systems, SA. Device class: 2.

Clearance details

Applicant: Technomed Medical Systems, SA
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-08
Decision date: 2009-07-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mount Dora, FL, 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

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.