ECONOLITH EM1000— 510(k) K063504

Substantially Equivalent

Medispec, Ltd.

FDA 510(k) clearance K063504 for ECONOLITH EM1000, Substantially Equivalent on 2007-03-09. Applicant: Medispec, Ltd..

Clearance details

Applicant: Medispec, Ltd.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2006-11-20
Decision date: 2007-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Germantown, MD, 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.