DeviceClearance

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

Substantially Equivalent

Convatec

FDA 510(k) clearance K260737 for Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16) +2 more, Substantially Equivalent on 2026-08-05. Applicant: Convatec. Device class: 2.

Summary

Convatec's submission covers Cure Aqua Ready to Use Hydrophilic Intermittent Catheters in three listed versions: Female (CH06 to CH16), Male Straight (CH06 to CH18), and Male Coude (CH10 to CH18). The product code is EZD, straight catheters.

Class II, 21 CFR 876.5130. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).

Convatec filed from Flintshire, United Kingdom. FDA found it substantially equivalent 152 calendar days after receipt (March 6 to August 5, 2026).

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
Product code EZD
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Flintshire, GB
Download summary PDFView on FDA.gov ↗

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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, through . 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.