K254170
- 510(k) number
- K254170
- Device name
- Percutaneous Endoscopic Gastrostomy (PEG) Kit
- Applicant
- Degania Silicone , Ltd. IL
- Product code
- PIF — Gastrointestinal Tubes With Enteral Specific Connect
- Decision date
- 2026-03-20
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K254170.pdf
Official FDA record: K254170
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.