MEDCOMP T-3— 510(k) K033570

Substantially Equivalent

Medcomp

FDA 510(k) clearance K033570 for MEDCOMP T-3, Substantially Equivalent on 2004-09-16. Applicant: Medcomp.

Clearance details

Applicant: Medcomp
Product code: 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

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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.