EZ-Protect Hydrophilic Closed System Intermittent Catheter +1 more— 510(k) K251274

Name: FDA 510(k) clearance K251274
Creator: U.S. Food and Drug Administration
Published: 2026-01-29

Unknown

HR Healthcare

FDA 510(k) clearance K251274 for EZ-Protect Hydrophilic Closed System Intermittent Catheter +1 more, Unknown on 2026-01-29. Applicant: HR Healthcare. Device class: 2.

Clearance details

Device name as filed: EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits
Applicant: HR Healthcare
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2025-04-24
Decision date: 2026-01-29
Decision: Unknown
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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K253295 — Coude Sleeved IC; Coude Plus Sleeved IC2026-05-18

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K260502 — Liv Pre-lubricated Intermittent Catheter2026-03-12

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.