K260394
- 510(k) number
- K260394
- Device name
- Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
- Applicant
- Hangzhou Jimushi Meditech Co., Ltd. CN
- Product code
- EZD — Catheter, Straight
- Decision date
- 2026-06-24
- Date received
- 2026-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260394.pdf
Official FDA record: K260394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.