Mini ONE Enteral Extension Set— 510(k) K142989

Substantially Equivalent

Applied Medical Technology, Inc.

FDA 510(k) clearance K142989 for Mini ONE Enteral Extension Set, Substantially Equivalent on 2015-01-29. Applicant: Applied Medical Technology, Inc..

Clearance details

Applicant: Applied Medical Technology, Inc.
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2014-10-16
Decision date: 2015-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brecksville, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

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.