DORNIER COMPACT ALPHA LITHOTRIPTER— 510(k) K002929

Substantially Equivalent

Dornier Medtech America, Inc.

FDA 510(k) clearance K002929 for DORNIER COMPACT ALPHA LITHOTRIPTER, Substantially Equivalent on 2001-04-17. Applicant: Dornier Medtech America, Inc..

Clearance details

Applicant: Dornier Medtech America, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2000-09-20
Decision date: 2001-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
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.