SELF CATH CATHETER— 510(k) K100878

Clearance details

Applicant

Coloplast Manufacturing Us, LLC

Product code

Code EZD

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

2010-03-30

Decision date

2010-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

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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 →