K251178
- 510(k) number
- K251178
- Device name
- Ready to use Nelaton Catheter
- Applicant
- Jamjoom Fullcare Corporation CN
- Product code
- EZD — Catheter, Straight
- Decision date
- 2026-01-02
- Date received
- 2025-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251178.pdf
Official FDA record: K251178
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.