PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000— 510(k) K032958

Substantially Equivalent

United Medical Systems, Inc.

FDA 510(k) clearance K032958 for PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000, Substantially Equivalent on 2004-02-17. Applicant: United Medical Systems, Inc..

Clearance details

Applicant: United Medical Systems, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-22
Decision date: 2004-02-17
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.