K250481

Substantially Equivalent

Extension Feeding Set with ENFit Connectors

Applicant: SKY Medical, a.s.
Product code: PIF
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-19
Decision date: 2025-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Samorin, SK

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.