K251274

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

510(k) number
K251274
Device name
EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits
Applicant
HR Healthcare PA · US
Product code
EZD — Catheter, Straight
Decision date
2026-01-29
Date received
2025-04-24
Decision
Unknown
Clearance type
Traditional
Flag
Third-party review
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K251274.pdf

Official FDA record: K251274
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.