T3— 510(k) K123292

Name: FDA 510(k) clearance K123292
Creator: U.S. Food and Drug Administration
Published: 2013-06-11

Substantially Equivalent

Medcomp

FDA 510(k) clearance K123292 for T3, Substantially Equivalent on 2013-06-11. Applicant: Medcomp. Device class: 2.

Clearance details

Applicant: Medcomp
Product code: Code NIE
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2012-10-22
Decision date: 2013-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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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.