LOFRIC SINGLE USE URINARY CATHETER— 510(k) K113424

Name: FDA 510(k) clearance K113424
Creator: U.S. Food and Drug Administration
Published: 2012-04-17

Substantially Equivalent

Astra Tech AB

FDA 510(k) clearance K113424 for LOFRIC SINGLE USE URINARY CATHETER, Substantially Equivalent on 2012-04-17. Applicant: Astra Tech AB. Device class: 2.

Clearance details

Applicant: Astra Tech AB
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2011-11-21
Decision date: 2012-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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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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.