GEMINI LITHOTRIPTER— 510(k) K121656

Substantially Equivalent

Dornier Medtech America, Inc.

FDA 510(k) clearance K121656 for GEMINI LITHOTRIPTER, Substantially Equivalent on 2012-09-24. Applicant: Dornier Medtech America, Inc..

Clearance details

Applicant: Dornier Medtech America, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2012-06-05
Decision date: 2012-09-24
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.