PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER— 510(k) K072538

Substantially Equivalent

United Medical Systems, Inc.

FDA 510(k) clearance K072538 for PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER, Substantially Equivalent on 2008-01-30. Applicant: United Medical Systems, Inc..

Clearance details

Applicant: United Medical Systems, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2007-09-07
Decision date: 2008-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.