Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection— 510(k) K213174

Substantially Equivalent

Cardinalhealth

FDA 510(k) clearance K213174 for Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection, Substantially Equivalent on 2022-05-19. Applicant: Cardinalhealth.

Clearance details

Applicant: Cardinalhealth
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-28
Decision date: 2022-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, 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.