FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS— 510(k) K142012

Name: FDA 510(k) clearance K142012
Creator: U.S. Food and Drug Administration
Published: 2014-11-20

Substantially Equivalent

Corpak Medsystems

FDA 510(k) clearance K142012 for FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS, Substantially Equivalent on 2014-11-20. Applicant: Corpak Medsystems. Device class: 2.

Clearance details

Applicant: Corpak Medsystems
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2014-07-24
Decision date: 2014-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo Grove, IL, US

Download summary PDF View on FDA.gov ↗

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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.