Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16) +2 more— 510(k) K260737

Clearance details

Device name as filed

Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).

Applicant

Convatec

Product code

Code EZD

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

2026-03-06

Decision date

2026-08-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Flintshire, GB

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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 →