K132672

Substantially Equivalent

EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER

Applicant: Dornier Medtech America
Product code: LNS
Advisory panel: Gastroenterology, Urology
Date received: 2013-08-27
Decision date: 2013-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Kennesaw, GA, US

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.