GentleCath Air for Women (3 models)— 510(k) K232665

Name: FDA 510(k) clearance K232665
Creator: U.S. Food and Drug Administration
Published: 2024-01-25

Substantially Equivalent

Convatec

FDA 510(k) clearance K232665 for GentleCath Air for Women (3 models), Substantially Equivalent on 2024-01-25. Applicant: Convatec. Device class: 2.

Clearance details

Device name as filed: GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
Applicant: Convatec
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2023-08-31
Decision date: 2024-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flintshire, GB

Download summary PDF View 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, 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.