Extension Feeding Set with ENFit Connectors— 510(k) K250481

Name: FDA 510(k) clearance K250481
Creator: U.S. Food and Drug Administration
Published: 2025-04-18

Substantially Equivalent

SKY Medical, a.s.

FDA 510(k) clearance K250481 for Extension Feeding Set with ENFit Connectors, Substantially Equivalent on 2025-04-18. Applicant: SKY Medical, a.s.. Device class: 2.

Clearance details

Applicant: SKY Medical, a.s.
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-19
Decision date: 2025-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Samorin, SK

Download summary PDF View on FDA.gov ↗

Recent devices under product code PIF

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K260110 — danumed Extension Set for Gastrostomy Button2026-09-10
K253715 — Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more2026-08-26
K254170 — Percutaneous Endoscopic Gastrostomy (PEG) Kit2026-03-20
K242917 — Enteral Drainage System, Enteral Medicine straw2025-06-18
K240052 — Disposable Enteral Feeding Sets2024-07-03

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.