K250481
- 510(k) number
- K250481
- Device name
- Extension Feeding Set with ENFit Connectors
- Applicant
- SKY Medical, a.s. SK
- Product code
- PIF — Gastrointestinal Tubes With Enteral Specific Connect
- Decision date
- 2025-04-18
- Date received
- 2025-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250481.pdf
Official FDA record: K250481
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.