Salem Sump Dual Lumen Stomach Tube with Multi-functional Port— 510(k) K150711

Substantially Equivalent

Covidien

FDA 510(k) clearance K150711 for Salem Sump Dual Lumen Stomach Tube with Multi-functional Port, Substantially Equivalent on 2015-10-08. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2015-03-19
Decision date: 2015-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, 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.