K033570

Substantially Equivalent

MEDCOMP T-3

Applicant: Medcomp
Product code: NIE
Advisory panel: Gastroenterology, Urology
Date received: 2003-11-12
Decision date: 2004-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

Adverse events under product code NIE

product code NIE

Death: 9
Other: 1
Total: 10

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.