DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER— 510(k) K013471

Substantially Equivalent

E.S.W.L. Products, Inc.

FDA 510(k) clearance K013471 for DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER, Substantially Equivalent on 2002-04-29. Applicant: E.S.W.L. Products, Inc..

Clearance details

Applicant: E.S.W.L. Products, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2001-10-18
Decision date: 2002-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, 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.