EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER— 510(k) K130729

Substantially Equivalent

Dornier Medtech Systems

FDA 510(k) clearance K130729 for EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER, Substantially Equivalent on 2013-05-14. Applicant: Dornier Medtech Systems.

Clearance details

Applicant: Dornier Medtech Systems
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-18
Decision date: 2013-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

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.