CLASSIC INTERMITTENT CATHETER— 510(k) K132619

Substantially Equivalent

Flexicare Medical, Ltd.

FDA 510(k) clearance K132619 for CLASSIC INTERMITTENT CATHETER, Substantially Equivalent on 2013-10-11. Applicant: Flexicare Medical, Ltd..

Clearance details

Applicant: Flexicare Medical, Ltd.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2013-08-21
Decision date: 2013-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mid Glamorgan, GB

Download summary PDF View on FDA.gov ↗

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.